Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) (NCT NCT05712720)
NCT ID: NCT05712720
Last Updated: 2026-09-01
Results Overview
Change from baseline in Central Subfield Thickness (CST), as measured by Spectral Domain Ocular Coherence Tomography (SD-OCT), compared to placebo. Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-09-01
Participant Flow
Participants were recruited based on physician referral. Out of 32 study centers involved in the study, 10 did not enroll participants. The first participant was enrolled on February 6, 2023 and the last participant was enrolled on December 22, 2023.
Of 229 screened participants, 94 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Group 1 - 50 mg RZ402
Participants received one 50 mg RZ402 tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 2 - 200 mg RZ402
RZ402 200mg oral tablet, once daily for 3 months
|
Group 3 - 400 mg RZ402
RZ402 400mg oral tablet, once daily for 3 months
|
Group 4 - Placebo
Participants received one 50 mg placebo tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
24
|
24
|
|
Overall Study
Safety Set
|
23
|
23
|
24
|
24
|
|
Overall Study
Full Analysis Set
|
22
|
23
|
24
|
24
|
|
Overall Study
Per Protocol Set
|
16
|
20
|
18
|
22
|
|
Overall Study
Pharmacokinetics Set
|
22
|
23
|
24
|
0
|
|
Overall Study
COMPLETED
|
18
|
22
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Women-only Analysis Population
Baseline characteristics by cohort
| Measure |
Group 1 - 50 mg RZ402
n=22 Participants
Participants received one 50 mg RZ402 tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 2 - 200 mg RZ402
n=23 Participants
RZ402 200mg oral tablet, once daily for 3 months
|
Group 3 - 400 mg RZ402
n=24 Participants
RZ402 400mg oral tablet, once daily for 3 months
|
Group 4 - Placebo
n=24 Participants
Participants received one 50 mg placebo tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.95 years
STANDARD_DEVIATION 6.67 • n=22 Participants
|
60.04 years
STANDARD_DEVIATION 11.51 • n=23 Participants
|
62.13 years
STANDARD_DEVIATION 8.33 • n=24 Participants
|
63.38 years
STANDARD_DEVIATION 7.72 • n=24 Participants
|
61.66 years
STANDARD_DEVIATION 8.70 • n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=22 Participants
|
13 Participants
n=23 Participants
|
9 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
40 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=22 Participants
|
10 Participants
n=23 Participants
|
15 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
53 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=22 Participants
|
4 Participants
n=23 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=22 Participants
|
17 Participants
n=23 Participants
|
16 Participants
n=24 Participants
|
21 Participants
n=24 Participants
|
72 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=22 Participants
|
5 Participants
n=23 Participants
|
7 Participants
n=24 Participants
|
7 Participants
n=24 Participants
|
22 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=22 Participants
|
17 Participants
n=23 Participants
|
17 Participants
n=24 Participants
|
17 Participants
n=24 Participants
|
69 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=93 Participants
|
|
Women of Child-bearing Potential
Yes :
|
0 Female Participants
n=10 Participants • Women-only Analysis Population
|
1 Female Participants
n=13 Participants • Women-only Analysis Population
|
0 Female Participants
n=9 Participants • Women-only Analysis Population
|
0 Female Participants
n=8 Participants • Women-only Analysis Population
|
1 Female Participants
n=40 Participants • Women-only Analysis Population
|
|
Women of Child-bearing Potential
No :
|
10 Female Participants
n=10 Participants • Women-only Analysis Population
|
12 Female Participants
n=13 Participants • Women-only Analysis Population
|
9 Female Participants
n=9 Participants • Women-only Analysis Population
|
8 Female Participants
n=8 Participants • Women-only Analysis Population
|
39 Female Participants
n=40 Participants • Women-only Analysis Population
|
|
Height
|
170.52 centimeters
STANDARD_DEVIATION 8.73 • n=22 Participants
|
165.77 centimeters
STANDARD_DEVIATION 9.28 • n=23 Participants
|
168.61 centimeters
STANDARD_DEVIATION 8.93 • n=24 Participants
|
170.92 centimeters
STANDARD_DEVIATION 10.90 • n=24 Participants
|
168.95 centimeters
STANDARD_DEVIATION 9.58 • n=93 Participants
|
|
Weight
|
89.12 kilograms
STANDARD_DEVIATION 20.23 • n=22 Participants
|
85.40 kilograms
STANDARD_DEVIATION 24.25 • n=23 Participants
|
89.50 kilograms
STANDARD_DEVIATION 23.01 • n=24 Participants
|
85.31 kilograms
STANDARD_DEVIATION 19.84 • n=24 Participants
|
87.32 kilograms
STANDARD_DEVIATION 21.65 • n=93 Participants
|
|
Body Mass Index
|
30.63 kilograms per meter squared
STANDARD_DEVIATION 6.78 • n=22 Participants
|
30.70 kilograms per meter squared
STANDARD_DEVIATION 6.76 • n=23 Participants
|
31.48 kilograms per meter squared
STANDARD_DEVIATION 8.13 • n=24 Participants
|
29.08 kilograms per meter squared
STANDARD_DEVIATION 5.84 • n=24 Participants
|
30.47 kilograms per meter squared
STANDARD_DEVIATION 6.88 • n=93 Participants
|
|
Duration of Diabetes
|
15.82 years
STANDARD_DEVIATION 9.50 • n=22 Participants • Three participants in the 400 mg RZ402 group could not remember when they were first diagnosed with diabetes.
|
17.17 years
STANDARD_DEVIATION 11.18 • n=23 Participants • Three participants in the 400 mg RZ402 group could not remember when they were first diagnosed with diabetes.
|
17.90 years
STANDARD_DEVIATION 8.96 • n=21 Participants • Three participants in the 400 mg RZ402 group could not remember when they were first diagnosed with diabetes.
|
13.08 years
STANDARD_DEVIATION 9.70 • n=24 Participants • Three participants in the 400 mg RZ402 group could not remember when they were first diagnosed with diabetes.
|
15.92 years
STANDARD_DEVIATION 9.90 • n=90 Participants • Three participants in the 400 mg RZ402 group could not remember when they were first diagnosed with diabetes.
|
|
HbA1C
|
7.44 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.14 • n=22 Participants • Baseline HbA1c was not collected in one placebo participant; this was listed as a protocol deviation.
|
7.96 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.54 • n=23 Participants • Baseline HbA1c was not collected in one placebo participant; this was listed as a protocol deviation.
|
7.32 Percentage of glycated hemoglobin
STANDARD_DEVIATION 0.87 • n=24 Participants • Baseline HbA1c was not collected in one placebo participant; this was listed as a protocol deviation.
|
7.28 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.10 • n=23 Participants • Baseline HbA1c was not collected in one placebo participant; this was listed as a protocol deviation.
|
7.50 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.20 • n=92 Participants • Baseline HbA1c was not collected in one placebo participant; this was listed as a protocol deviation.
|
|
Central Subfield Thickness, Study Eye
|
460.36 µm
STANDARD_DEVIATION 96.74 • n=22 Participants
|
435.43 µm
STANDARD_DEVIATION 127.06 • n=23 Participants
|
428.60 µm
STANDARD_DEVIATION 87.88 • n=24 Participants
|
408.02 µm
STANDARD_DEVIATION 82.77 • n=24 Participants
|
432.49 µm
STANDARD_DEVIATION 99.94 • n=93 Participants
|
|
Central Subfield Thickness, Fellow Eye
|
376.68 µm
STANDARD_DEVIATION 126.91 • n=22 Participants
|
331.74 µm
STANDARD_DEVIATION 95.85 • n=23 Participants
|
337.63 µm
STANDARD_DEVIATION 75.94 • n=24 Participants
|
336.96 µm
STANDARD_DEVIATION 62.52 • n=24 Participants
|
345.24 µm
STANDARD_DEVIATION 92.78 • n=93 Participants
|
|
Central Subfield Thickness <400 µm, Study Eye
|
356.00 µm
STANDARD_DEVIATION 23.14 • n=8 Participants • This baseline measure represents the subgroup of participants who were in the \<400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
352.96 µm
STANDARD_DEVIATION 22.37 • n=13 Participants • This baseline measure represents the subgroup of participants who were in the \<400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
357.96 µm
STANDARD_DEVIATION 17.37 • n=12 Participants • This baseline measure represents the subgroup of participants who were in the \<400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
360.10 µm
STANDARD_DEVIATION 27.13 • n=15 Participants • This baseline measure represents the subgroup of participants who were in the \<400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
356.95 µm
STANDARD_DEVIATION 22.48 • n=48 Participants • This baseline measure represents the subgroup of participants who were in the \<400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
|
Central Subfield Thickness ≥400 µm, Study Eye
|
520.00 µm
STANDARD_DEVIATION 65.55 • n=14 Participants • This baseline measure represents the subgroup of participants who were in the ≥400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
542.65 µm
STANDARD_DEVIATION 127.27 • n=10 Participants • This baseline measure represents the subgroup of participants who were in the ≥400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
499.25 µm
STANDARD_DEVIATION 70.40 • n=12 Participants • This baseline measure represents the subgroup of participants who were in the ≥400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
487.89 µm
STANDARD_DEVIATION 83.22 • n=9 Participants • This baseline measure represents the subgroup of participants who were in the ≥400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
513.08 µm
STANDARD_DEVIATION 86.47 • n=45 Participants • This baseline measure represents the subgroup of participants who were in the ≥400 μm central subfield thickness stratum at baseline, as defined by the study's stratification criteria.
|
|
Best Corrected Visual Acuity, Study Eye
|
69.57 letters
STANDARD_DEVIATION 8.44 • n=22 Participants
|
70.28 letters
STANDARD_DEVIATION 12.27 • n=23 Participants
|
70.46 letters
STANDARD_DEVIATION 6.70 • n=24 Participants
|
69.56 letters
STANDARD_DEVIATION 8.81 • n=24 Participants
|
69.97 letters
STANDARD_DEVIATION 9.12 • n=93 Participants
|
|
Best Corrected Visual Acuity, Fellow Eye
|
79.20 letters
STANDARD_DEVIATION 9.56 • n=22 Participants
|
73.87 letters
STANDARD_DEVIATION 12.35 • n=23 Participants
|
76.21 letters
STANDARD_DEVIATION 7.68 • n=24 Participants
|
75.76 letters
STANDARD_DEVIATION 9.60 • n=24 Participants
|
76.22 letters
STANDARD_DEVIATION 9.94 • n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Diabetic retinopathy (DR) Absent (Level 10)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Questionable DR (Level 14 or 15)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Microaneurysms Only
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Mild non-proliferative diabetic retinopathy (NPDR) (Level 35)
|
14 Participants
n=22 Participants
|
13 Participants
n=23 Participants
|
17 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
59 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Moderate NPDR (Level 43)
|
2 Participants
n=22 Participants
|
8 Participants
n=23 Participants
|
7 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
23 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Moderately Severe NPDR (Level 47)
|
6 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
9 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Severe NPDR (Level 53)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Mild proliferative diabetic retinopathy/panretinal photocoagulation (PDR/PRP) Present (Level 61)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Moderate PDR (Level 65)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
High-risk PDR (Level 71)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
High-risk PDR (Level 75)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Advanced PDR (Level 85)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Study Eye
Cannot Grade (Level 90)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Diabetic retinopathy (DR) Absent (Level 10)
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Questionable DR (Level 14 or 15)
|
0 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Microaneurysms Only (Level 20)
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Mild non-proliferative diabetic retinopathy (NPDR) (Level 35)
|
11 Participants
n=22 Participants
|
11 Participants
n=23 Participants
|
18 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
54 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Moderate NPDR (Level 43)
|
6 Participants
n=22 Participants
|
6 Participants
n=23 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
20 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Moderately Severe NPDR
|
4 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Severe NPDR (Level 53)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Mild proliferative diabetic retinopathy/panretinal photocoagulation (PDR/PRP) Present (Level 61)
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Moderate PDR (Level 65)
|
0 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
High-risk PDR (Level 71)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
High-risk PDR (Level 75)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Advanced PDR (Level 85)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=93 Participants
|
|
Diabetic Retinopathy Severity Scale, Fellow Eye
Cannot Grade (Level 90)
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=93 Participants
|
|
History of prior anti-vascular endothelial growth factor injections
Study Eye · Yes
|
5 Participants
n=22 Participants
|
6 Participants
n=23 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
22 Participants
n=93 Participants
|
|
History of prior anti-vascular endothelial growth factor injections
Study Eye · No
|
17 Participants
n=22 Participants
|
17 Participants
n=23 Participants
|
18 Participants
n=24 Participants
|
19 Participants
n=24 Participants
|
71 Participants
n=93 Participants
|
|
History of prior anti-vascular endothelial growth factor injections
Fellow Eye · Yes
|
3 Participants
n=22 Participants
|
11 Participants
n=23 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
25 Participants
n=93 Participants
|
|
History of prior anti-vascular endothelial growth factor injections
Fellow Eye · No
|
19 Participants
n=22 Participants
|
12 Participants
n=23 Participants
|
19 Participants
n=24 Participants
|
18 Participants
n=24 Participants
|
68 Participants
n=93 Participants
|
|
Number of anti-vascular endothelial growth factor injections
Study Eye
|
0.36 number of injections
STANDARD_DEVIATION 0.79 • n=22 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
0.52 number of injections
STANDARD_DEVIATION 0.99 • n=23 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
0.48 number of injections
STANDARD_DEVIATION 0.99 • n=23 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
0.33 number of injections
STANDARD_DEVIATION 0.76 • n=24 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
0.42 number of injections
STANDARD_DEVIATION 0.88 • n=92 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
|
Number of anti-vascular endothelial growth factor injections
Fellow Eye
|
0.27 number of injections
STANDARD_DEVIATION 0.88 • n=22 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
0.68 number of injections
STANDARD_DEVIATION 1.06 • n=19 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
0.43 number of injections
STANDARD_DEVIATION 1.04 • n=23 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
0.57 number of injections
STANDARD_DEVIATION 1.27 • n=23 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
0.48 number of injections
STANDARD_DEVIATION 1.07 • n=87 Participants • One participant in the 400 mg RZ402 group could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Study Eye; four-, one-, and one participant(s) in the 200 mg RZ402, 400 mg RZ402, and placebo groups, respectively, could not recall with exact certainty the number of anti-VEGF injections they had previously received in the Fellow Eye.
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Patients early-terminated and/or missed assessment
Change from baseline in Central Subfield Thickness (CST), as measured by Spectral Domain Ocular Coherence Tomography (SD-OCT), compared to placebo. Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.
Outcome measures
| Measure |
Group 4 - Placebo
n=23 Participants
Participants received one 50 mg placebo tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 1 - 50 mg RZ402
n=20 Participants
Participants received one 50 mg RZ402 tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 2 - 200 mg RZ402
n=21 Participants
RZ402 200mg oral tablet, once daily for 3 months
|
Group 3 - 400 mg RZ402
n=21 Participants
RZ402 400mg oral tablet, once daily for 3 months
|
|---|---|---|---|---|
|
Change in Central Subfield Thickness in Study Eye
|
23.39 µm
Interval -0.17 to 46.95
|
-12.38 µm
Interval -37.4 to 12.64
|
-13.13 µm
Interval -35.38 to 9.12
|
-4.28 µm
Interval -26.54 to 17.97
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients early-terminated and/or missed assessment
Change from baseline in Best Corrected Visual Acuity (BCVA) in the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, compared to placebo. BCVA was assessed by ETDRS chart at 4 meters. This scale is expressed as the total number of ETDRS letters correctly identified at 4 meters. The possible range for the ETDRS BCVA letter score at 4 meters in this study is from 0 to 100 letters (higher scores indicating better visual acuity). Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.
Outcome measures
| Measure |
Group 4 - Placebo
n=23 Participants
Participants received one 50 mg placebo tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 1 - 50 mg RZ402
n=20 Participants
Participants received one 50 mg RZ402 tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 2 - 200 mg RZ402
n=21 Participants
RZ402 200mg oral tablet, once daily for 3 months
|
Group 3 - 400 mg RZ402
n=21 Participants
RZ402 400mg oral tablet, once daily for 3 months
|
|---|---|---|---|---|
|
Change in Best Corrected Visual Acuity in Study Eye
|
4.05 letters
Interval 1.73 to 6.38
|
0.92 letters
Interval -1.52 to 3.37
|
2.53 letters
Interval 0.52 to 4.54
|
1.74 letters
Interval -0.27 to 3.75
|
SECONDARY outcome
Timeframe: 12 weeksNumber of participants with a gain from baseline of ≥5 letters in BCVA by ETDRS chart at 4 meters, compared to placebo. Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.
Outcome measures
| Measure |
Group 4 - Placebo
n=24 Participants
Participants received one 50 mg placebo tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 1 - 50 mg RZ402
n=22 Participants
Participants received one 50 mg RZ402 tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 2 - 200 mg RZ402
n=23 Participants
RZ402 200mg oral tablet, once daily for 3 months
|
Group 3 - 400 mg RZ402
n=24 Participants
RZ402 400mg oral tablet, once daily for 3 months
|
|---|---|---|---|---|
|
Gain of ≥5 Letters in Best Corrected Visual Acuity in Study Eye
|
14 Participants
|
3 Participants
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeksNumber of participants with a loss from baseline of ≤5 letters in BCVA by ETDRS chart at 4 meters, compared to placebo. Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.
Outcome measures
| Measure |
Group 4 - Placebo
n=24 Participants
Participants received one 50 mg placebo tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 1 - 50 mg RZ402
n=22 Participants
Participants received one 50 mg RZ402 tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 2 - 200 mg RZ402
n=23 Participants
RZ402 200mg oral tablet, once daily for 3 months
|
Group 3 - 400 mg RZ402
n=24 Participants
RZ402 400mg oral tablet, once daily for 3 months
|
|---|---|---|---|---|
|
Loss of ≥5 Letters in Best Corrected Visual Acuity in Study Eye
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients early-terminated and/or missed assessment
Change from baseline in Diabetic Retinopathy Severity Score (DRSS), compared to placebo. Color fundus photographs were taken in both eyes at screening and at specified on-site visits to evaluate retinal anatomy and grade DRSS. Fundus photography was conducted pre-dose on applicable visits. A ≥2-step worsening in DRSS markedly increases the likelihood of developing PDR, whereas a ≥2-step improvement in DRSS substantially reduces the incidence of new PDR events compared with sham (approximately three-fold lower).
Outcome measures
| Measure |
Group 4 - Placebo
n=23 Participants
Participants received one 50 mg placebo tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 1 - 50 mg RZ402
n=20 Participants
Participants received one 50 mg RZ402 tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 2 - 200 mg RZ402
n=20 Participants
RZ402 200mg oral tablet, once daily for 3 months
|
Group 3 - 400 mg RZ402
n=21 Participants
RZ402 400mg oral tablet, once daily for 3 months
|
|---|---|---|---|---|
|
Change in Diabetic Retinopathy Severity Score
≥3 Step Improvement
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Diabetic Retinopathy Severity Score
2 Step Improvement
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Diabetic Retinopathy Severity Score
1 Step Improvement
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Change in Diabetic Retinopathy Severity Score
No Change
|
21 Participants
|
18 Participants
|
14 Participants
|
19 Participants
|
|
Change in Diabetic Retinopathy Severity Score
1 Step Worsening
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Change in Diabetic Retinopathy Severity Score
2 Step Worsening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Diabetic Retinopathy Severity Score
≥3 Step Worsening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1 - 50 mg RZ402
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 2 - 200 mg RZ402
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 3 - 400 mg RZ402
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 4 - Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 - 50 mg RZ402
n=23 participants at risk
Participants received one 50 mg RZ402 tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 2 - 200 mg RZ402
n=23 participants at risk
RZ402 200mg oral tablet, once daily for 3 months
|
Group 3 - 400 mg RZ402
n=24 participants at risk
RZ402 400mg oral tablet, once daily for 3 months
|
Group 4 - Placebo
n=24 participants at risk
Participants received one 50 mg placebo tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
Other adverse events
| Measure |
Group 1 - 50 mg RZ402
n=23 participants at risk
Participants received one 50 mg RZ402 tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
Group 2 - 200 mg RZ402
n=23 participants at risk
RZ402 200mg oral tablet, once daily for 3 months
|
Group 3 - 400 mg RZ402
n=24 participants at risk
RZ402 400mg oral tablet, once daily for 3 months
|
Group 4 - Placebo
n=24 participants at risk
Participants received one 50 mg placebo tablet and two 200 mg placebo tablets orally once daily for 12 weeks.
|
|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Otitis externa
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
8.3%
2/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
8.7%
2/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Vascular disorders
Poor venous access
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Vascular disorders
Thrombosis
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Eye disorders
Diabetic retinopathy
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Eye disorders
Cataract
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Eye disorders
Eye pain
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Nervous system disorders
Dementia
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
General disorders
Chills
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
General disorders
Fatigue
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
General disorders
Edema peripheral
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Investigations
Cardiac murmur
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Investigations
Lipase increased
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
12.5%
3/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.3%
1/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
8.7%
2/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
Genital herpes
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/23 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/24 • From enrollment until end of follow-up, up to 16 weeks
|
4.2%
1/24 • From enrollment until end of follow-up, up to 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place