Trial Outcomes & Findings for A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema (NCT NCT02121262)
NCT ID: NCT02121262
Last Updated: 2020-11-17
Results Overview
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. The average change was computed by subtracting the baseline BCVA from the area under the BCVA curve (AUC) divided by the total follow-up time for each participant. Analysis of covariance (ANCOVA) model was used for the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
284 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2020-11-17
Participant Flow
Participant milestones
| Measure |
Laser Photocoagulation
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
|
Dexamethasone
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
145
|
|
Overall Study
Treated
|
129
|
145
|
|
Overall Study
Modified Intent-to-treat Population
|
127
|
145
|
|
Overall Study
COMPLETED
|
108
|
135
|
|
Overall Study
NOT COMPLETED
|
31
|
10
|
Reasons for withdrawal
| Measure |
Laser Photocoagulation
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
|
Dexamethasone
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
|
Overall Study
Personal Reasons
|
19
|
5
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Participant Dropped-out
|
0
|
1
|
|
Overall Study
Participant was Deemed Unsuitable
|
1
|
0
|
|
Overall Study
Consent Withdrawn
|
1
|
0
|
Baseline Characteristics
Data for Total Macular Leakage Area was only available for 125 participants in the Laser Photocoagulation arm.
Baseline characteristics by cohort
| Measure |
Laser Photocoagulation
n=127 Participants
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
|
Dexamethasone
n=145 Participants
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 7.73 • n=99 Participants
|
59.1 years
STANDARD_DEVIATION 8.08 • n=107 Participants
|
59.3 years
STANDARD_DEVIATION 7.91 • n=206 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
127 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
272 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Chinese
|
113 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
242 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
BCVA in the Study Eye
|
55.1 letters
STANDARD_DEVIATION 10.32 • n=99 Participants
|
55.7 letters
STANDARD_DEVIATION 11.44 • n=107 Participants
|
55.4 letters
STANDARD_DEVIATION 10.91 • n=206 Participants
|
|
Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) in the Study Eye
|
482.1 microns
STANDARD_DEVIATION 154.39 • n=99 Participants
|
491.2 microns
STANDARD_DEVIATION 160.80 • n=107 Participants
|
486.9 microns
STANDARD_DEVIATION 157.61 • n=206 Participants
|
|
Total Macular Leakage Area by Fluorescein Angiography (FA) in the Study Eye
|
30.076 mm^2
n=99 Participants • Data for Total Macular Leakage Area was only available for 125 participants in the Laser Photocoagulation arm.
|
29.644 mm^2
n=107 Participants • Data for Total Macular Leakage Area was only available for 125 participants in the Laser Photocoagulation arm.
|
29.8 mm^2
n=206 Participants • Data for Total Macular Leakage Area was only available for 125 participants in the Laser Photocoagulation arm.
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement.
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. The average change was computed by subtracting the baseline BCVA from the area under the BCVA curve (AUC) divided by the total follow-up time for each participant. Analysis of covariance (ANCOVA) model was used for the analysis.
Outcome measures
| Measure |
Laser Photocoagulation
n=127 Participants
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
|
Dexamethasone
n=145 Participants
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
|
|---|---|---|
|
Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye
|
1.4 letters
Standard Error 0.65
|
4.3 letters
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement.
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye.
Outcome measures
| Measure |
Laser Photocoagulation
n=127 Participants
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
|
Dexamethasone
n=145 Participants
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
|
|---|---|---|
|
Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye
|
10.2 percentage of participants
|
11.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement. Last observation carried forward (LOCF) was used
CRT was assessed using SD-OCT, a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Laser Photocoagulation
n=127 Participants
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
|
Dexamethasone
n=145 Participants
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
|
|---|---|---|
|
Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye
|
-120.3 microns
Standard Error 13.20
|
-209.5 microns
Standard Error 12.27
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement. LOCF was used. Overall number of participants analyzed is the number of participants with data available for analyses.
FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Early and transit images were taken of the study eye. Mid- and late-phase images were taken of the study and non-study eye. Electronic FA images were collected for evaluation by a reading center. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Laser Photocoagulation
n=125 Participants
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
|
Dexamethasone
n=145 Participants
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
|
|---|---|---|
|
Change From Baseline in Total Macular Leakage Area by FA in the Study Eye
|
-0.637 mm^2
Standard Error 0.8133
|
-8.367 mm^2
Standard Error 0.7482
|
Adverse Events
Laser Photocoagulation
Serious events: 21 serious events
Other events: 51 other events
Deaths: 1 deaths
Dexamethasone
Serious events: 35 serious events
Other events: 99 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Laser Photocoagulation
n=129 participants at risk
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
|
Dexamethasone
n=145 participants at risk
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
2.8%
4/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Cardiac disorders
Coronary artery disease
|
3.1%
4/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
1.4%
2/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
1.4%
2/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Cardiac disorders
Angina pectoris
|
1.6%
2/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Cataract
|
1.6%
2/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
5.5%
8/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Vitreous haemorrhage
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Glaucoma
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Visual impairment
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Macular hole
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Gastrointestinal disorders
Ascites
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Gastrointestinal disorders
Gastritis
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
1.4%
2/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
1.4%
2/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.3%
3/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
1.4%
2/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Nervous system disorders
Cerebral infarction
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.69%
1/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Nervous system disorders
Dizziness
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
1.6%
2/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
1.4%
2/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
0.00%
0/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Vascular disorders
Hypertension
|
2.3%
3/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
1.4%
2/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
Other adverse events
| Measure |
Laser Photocoagulation
n=129 participants at risk
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
|
Dexamethasone
n=145 participants at risk
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
|
|---|---|---|
|
Eye disorders
Cataract
|
6.2%
8/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
11.0%
16/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Visual impairment
|
14.0%
18/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
10.3%
15/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Ocular hypertension
|
0.78%
1/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
6.9%
10/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Dry eye
|
5.4%
7/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
5.5%
8/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Eye disorders
Vitreous haemorrhage
|
6.2%
8/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
4.8%
7/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
8/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
9.0%
13/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Infections and infestations
Conjunctivitis
|
1.6%
2/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
9.0%
13/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
4/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
5.5%
8/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
8/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
2.8%
4/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
|
Investigations
Intraocular pressure increased
|
7.0%
9/129 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
34.5%
50/145 • From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER