Trial Outcomes & Findings for Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2) (NCT NCT01884597)
NCT ID: NCT01884597
Last Updated: 2017-10-09
Results Overview
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
From Baseline to Month 12
Results posted on
2017-10-09
Participant Flow
Participant milestones
| Measure |
Cohort 1
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
16
|
|
Overall Study
COMPLETED
|
4
|
2
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
Baseline characteristics by cohort
| Measure |
Cohort 1
n=4 Participants
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=2 Participants
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 Participants
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Age, Continuous
|
75.75 years
STANDARD_DEVIATION 13.72 • n=99 Participants
|
71.00 years
STANDARD_DEVIATION 19.80 • n=107 Participants
|
77.47 years
STANDARD_DEVIATION 8.37 • n=206 Participants
|
77.17 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
15 participants
n=206 Participants
|
21 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Month 12Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=2 Participants
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 Participants
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
BCVA
|
-3.50 number of letters read correctly
Standard Deviation 21.52
|
29.50 number of letters read correctly
Standard Deviation 24.75
|
8.60 number of letters read correctly
Standard Deviation 12.57
|
PRIMARY outcome
Timeframe: Baseline to M24Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24
Outcome measures
| Measure |
Cohort 1
n=4 Participants
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=2 Participants
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 Participants
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
BCVA
|
-5.75 number of letters read correctly
Standard Deviation 24.58
|
23.5 number of letters read correctly
Standard Deviation 44.54
|
5.13 number of letters read correctly
Standard Deviation 15.98
|
SECONDARY outcome
Timeframe: MonthlyIncidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
Outcome measures
| Measure |
Cohort 1
n=4 Participants
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=2 Participants
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 Participants
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
Ocular Adverse Events (AE)
|
0 Ocular adverse events
|
0 Ocular adverse events
|
0 Ocular adverse events
|
SECONDARY outcome
Timeframe: MonthlyIncidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
Outcome measures
| Measure |
Cohort 1
n=4 Participants
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=2 Participants
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 Participants
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
Systemic AEs
|
0 Number of Participants with Systemic AEs
|
0 Number of Participants with Systemic AEs
|
1 Number of Participants with Systemic AEs
|
SECONDARY outcome
Timeframe: at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24
Outcome measures
| Measure |
Cohort 1
n=4 Participants
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=2 Participants
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 Participants
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
BCVA
Baseline
|
55.00 number of letters read correctly
Standard Deviation 19.06
|
50.00 number of letters read correctly
Standard Deviation 28.28
|
62.80 number of letters read correctly
Standard Deviation 17.11
|
|
BCVA
Day 14
|
52.00 number of letters read correctly
Standard Deviation 18.92
|
52.50 number of letters read correctly
Standard Deviation 24.75
|
64.07 number of letters read correctly
Standard Deviation 18.47
|
|
BCVA
Month 1
|
47.00 number of letters read correctly
Standard Deviation 27.83
|
70.00 number of letters read correctly
Standard Deviation 8.49
|
65.67 number of letters read correctly
Standard Deviation 16.60
|
|
BCVA
Month 3
|
48.50 number of letters read correctly
Standard Deviation 32.60
|
78.50 number of letters read correctly
Standard Deviation 6.36
|
69.13 number of letters read correctly
Standard Deviation 18.19
|
|
BCVA
Month 6
|
47.50 number of letters read correctly
Standard Deviation 31.65
|
82.50 number of letters read correctly
Standard Deviation 4.95
|
69.33 number of letters read correctly
Standard Deviation 15.43
|
|
BCVA
Month 9
|
51.75 number of letters read correctly
Standard Deviation 32.90
|
72.50 number of letters read correctly
Standard Deviation 2.12
|
71.67 number of letters read correctly
Standard Deviation 9.64
|
|
BCVA
Month 12
|
51.50 number of letters read correctly
Standard Deviation 33.16
|
79.50 number of letters read correctly
Standard Deviation 3.54
|
71.40 number of letters read correctly
Standard Deviation 10.66
|
|
BCVA
Month 15
|
48.00 number of letters read correctly
Standard Deviation 34.97
|
80.50 number of letters read correctly
Standard Deviation 0.71
|
70.80 number of letters read correctly
Standard Deviation 10.35
|
|
BCVA
Month 18
|
48.00 number of letters read correctly
Standard Deviation 32.38
|
83.00 number of letters read correctly
Standard Deviation 4.24
|
69.93 number of letters read correctly
Standard Deviation 10.91
|
|
BCVA
Month 21
|
50.00 number of letters read correctly
Standard Deviation 33.34
|
67.50 number of letters read correctly
Standard Deviation 9.19
|
68.533 number of letters read correctly
Standard Deviation 12.14
|
|
BCVA
Month 24
|
49.25 number of letters read correctly
Standard Deviation 31.92
|
73.50 number of letters read correctly
Standard Deviation 16.26
|
67.93 number of letters read correctly
Standard Deviation 13.08
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Month 1-24Population: Patient in Cohort 2 missed several visits.
Optical Coherence Tomography (OCT) central macular and peripapillary thickness
Outcome measures
| Measure |
Cohort 1
n=4 Participants
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=2 Participants
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 Participants
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
Macular Edema
Baseline
|
370.25 microns
Standard Deviation 148.14
|
347.50 microns
Standard Deviation 194.45
|
282.47 microns
Standard Deviation 44.55
|
|
Macular Edema
Day 14
|
265.00 microns
Standard Deviation 69.58
|
251.00 microns
Standard Deviation 65.05
|
235.07 microns
Standard Deviation 35.45
|
|
Macular Edema
Month 1
|
276.25 microns
Standard Deviation 22.56
|
228.00 microns
Standard Deviation 24.04
|
216.67 microns
Standard Deviation 33.47
|
|
Macular Edema
Month 2
|
252.50 microns
Standard Deviation 15.46
|
218.50 microns
Standard Deviation 14.85
|
212.20 microns
Standard Deviation 33.06
|
|
Macular Edema
Month 3
|
244.25 microns
Standard Deviation 12.18
|
220.00 microns
Standard Deviation 12.73
|
216.29 microns
Standard Deviation 33.50
|
|
Macular Edema
Month 4
|
238.25 microns
Standard Deviation 16.60
|
224.00 microns
Standard Deviation 15.56
|
214.36 microns
Standard Deviation 26.33
|
|
Macular Edema
Month 5
|
245.75 microns
Standard Deviation 20.95
|
224.50 microns
Standard Deviation 12.02
|
215.53 microns
Standard Deviation 40.77
|
|
Macular Edema
Month 6
|
232.75 microns
Standard Deviation 24.70
|
224.00 microns
Standard Deviation 9.90
|
211.47 microns
Standard Deviation 36.32
|
|
Macular Edema
Month 7
|
234.00 microns
Standard Deviation 19.29
|
223.00 microns
Standard Deviation 12.73
|
215.67 microns
Standard Deviation 30.90
|
|
Macular Edema
Month 8
|
233.00 microns
Standard Deviation 16.79
|
232.00 microns
Standard Deviation NA
One patient missed a visit.
|
209.67 microns
Standard Deviation 34.01
|
|
Macular Edema
Month 9
|
229.75 microns
Standard Deviation 17.93
|
222.50 microns
Standard Deviation 9.19
|
203.29 microns
Standard Deviation 31.04
|
|
Macular Edema
Month 10
|
217.00 microns
Standard Deviation 7.00
|
233.00 microns
Standard Deviation NA
One patient missed a visit
|
215.80 microns
Standard Deviation 30.05
|
|
Macular Edema
Month 11
|
223.25 microns
Standard Deviation 19.87
|
228.50 microns
Standard Deviation 12.02
|
206.93 microns
Standard Deviation 32.04
|
|
Macular Edema
Month 12
|
225.00 microns
Standard Deviation 18.22
|
226.50 microns
Standard Deviation 9.19
|
207.80 microns
Standard Deviation 29.33
|
|
Macular Edema
Month 13
|
221.67 microns
Standard Deviation 17.16
|
222.00 microns
Standard Deviation 15.56
|
209.71 microns
Standard Deviation 39.34
|
|
Macular Edema
Month 14
|
244.50 microns
Standard Deviation 34.32
|
223.00 microns
Standard Deviation 15.56
|
211.27 microns
Standard Deviation 32.19
|
|
Macular Edema
Month 15
|
220.25 microns
Standard Deviation 17.56
|
228.50 microns
Standard Deviation 12.02
|
210.20 microns
Standard Deviation 29.27
|
|
Macular Edema
Month 16
|
220.25 microns
Standard Deviation 20.71
|
227.5 microns
Standard Deviation 10.61
|
212.00 microns
Standard Deviation 31.18
|
|
Macular Edema
Month 17
|
219.75 microns
Standard Deviation 22.51
|
238 microns
Standard Deviation NA
One patient missed a visit
|
209.29 microns
Standard Deviation 31.94
|
|
Macular Edema
Month 18
|
237075 microns
Standard Deviation 57.72
|
230.50 microns
Standard Deviation 14.85
|
213.67 microns
Standard Deviation 32.73
|
|
Macular Edema
Month 19
|
218.33 microns
Standard Deviation 24.54
|
231.5 microns
Standard Deviation 9.19
|
217.08 microns
Standard Deviation 41.69
|
|
Macular Edema
Month 20
|
216.00 microns
Standard Deviation 25.97
|
237 microns
Standard Deviation NA
Patient missed a visit
|
217.93 microns
Standard Deviation 36.11
|
|
Macular Edema
Month 21
|
214 microns
Standard Deviation 23.83
|
218.5 microns
Standard Deviation 17.68
|
209.07 microns
Standard Deviation 32.46
|
|
Macular Edema
Month 22
|
211.5 microns
Standard Deviation 27.01
|
239.50 microns
Standard Deviation 12.02
|
212.13 microns
Standard Deviation 36.50
|
|
Macular Edema
Month 23
|
209.25 microns
Standard Deviation 28.92
|
244.50 microns
Standard Deviation 21.92
|
216.08 microns
Standard Deviation 33.64
|
|
Macular Edema
Month 24
|
214.25 microns
Standard Deviation 22.65
|
231.00 microns
Standard Deviation 1.41
|
215.27 microns
Standard Deviation 38.83
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, 24Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography
Outcome measures
| Measure |
Cohort 1
n=15 Participants
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=2 Participants
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=4 Participants
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
PCV Anatomic Changes
Baseline (BVN)
|
0 Participants with PCV Anatomic Changes
|
0 Participants with PCV Anatomic Changes
|
0 Participants with PCV Anatomic Changes
|
|
PCV Anatomic Changes
Month 6 (BVN)
|
0 Participants with PCV Anatomic Changes
|
0 Participants with PCV Anatomic Changes
|
1 Participants with PCV Anatomic Changes
|
|
PCV Anatomic Changes
Month 12 (BVN)
|
2 Participants with PCV Anatomic Changes
|
0 Participants with PCV Anatomic Changes
|
1 Participants with PCV Anatomic Changes
|
|
PCV Anatomic Changes
Month 24 (BVN)
|
1 Participants with PCV Anatomic Changes
|
0 Participants with PCV Anatomic Changes
|
2 Participants with PCV Anatomic Changes
|
|
PCV Anatomic Changes
Baseline (PCV)
|
0 Participants with PCV Anatomic Changes
|
0 Participants with PCV Anatomic Changes
|
0 Participants with PCV Anatomic Changes
|
|
PCV Anatomic Changes
Month 6 (PCV)
|
3 Participants with PCV Anatomic Changes
|
2 Participants with PCV Anatomic Changes
|
8 Participants with PCV Anatomic Changes
|
|
PCV Anatomic Changes
Month 12 (PCV)
|
2 Participants with PCV Anatomic Changes
|
1 Participants with PCV Anatomic Changes
|
8 Participants with PCV Anatomic Changes
|
|
PCV Anatomic Changes
Month 24 (PCV)
|
4 Participants with PCV Anatomic Changes
|
2 Participants with PCV Anatomic Changes
|
9 Participants with PCV Anatomic Changes
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, 24Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam
Outcome measures
| Measure |
Cohort 1
n=4 Participants
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=2 Participants
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 Participants
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly
ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
Fundus Clinical Findings
Baseline
|
0 Participants with Fundus Findings
|
0 Participants with Fundus Findings
|
0 Participants with Fundus Findings
|
|
Fundus Clinical Findings
Month 6
|
1 Participants with Fundus Findings
|
2 Participants with Fundus Findings
|
8 Participants with Fundus Findings
|
|
Fundus Clinical Findings
Month 12
|
1 Participants with Fundus Findings
|
2 Participants with Fundus Findings
|
8 Participants with Fundus Findings
|
|
Fundus Clinical Findings
Month 24
|
1 Participants with Fundus Findings
|
2 Participants with Fundus Findings
|
8 Participants with Fundus Findings
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=4 participants at risk
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=3 participants at risk；n=2 participants at risk
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly
ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 participants at risk
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly
ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
25.0%
1/4 • Number of events 1 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/2 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/15 • Adverse event data include events starting on day 0 and ending at month 24.
|
Other adverse events
| Measure |
Cohort 1
n=4 participants at risk
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 2
n=3 participants at risk；n=2 participants at risk
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly
ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
Cohort 3
n=15 participants at risk
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly
ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
|
|---|---|---|---|
|
General disorders
Flu-like symptoms
|
0.00%
0/4 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/3 • Adverse event data include events starting on day 0 and ending at month 24.
|
6.7%
1/15 • Number of events 1 • Adverse event data include events starting on day 0 and ending at month 24.
|
|
General disorders
Rash
|
0.00%
0/4 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/3 • Adverse event data include events starting on day 0 and ending at month 24.
|
6.7%
1/15 • Number of events 2 • Adverse event data include events starting on day 0 and ending at month 24.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/4 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/3 • Adverse event data include events starting on day 0 and ending at month 24.
|
6.7%
1/15 • Number of events 1 • Adverse event data include events starting on day 0 and ending at month 24.
|
|
General disorders
Body ache, fever, hives
|
0.00%
0/4 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/3 • Adverse event data include events starting on day 0 and ending at month 24.
|
6.7%
1/15 • Number of events 1 • Adverse event data include events starting on day 0 and ending at month 24.
|
|
Investigations
Bone Marrow Tap
|
0.00%
0/4 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/3 • Adverse event data include events starting on day 0 and ending at month 24.
|
6.7%
1/15 • Number of events 1 • Adverse event data include events starting on day 0 and ending at month 24.
|
|
Nervous system disorders
Peripheral Neuropathy
|
0.00%
0/4 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/3 • Adverse event data include events starting on day 0 and ending at month 24.
|
6.7%
1/15 • Number of events 1 • Adverse event data include events starting on day 0 and ending at month 24.
|
|
Surgical and medical procedures
Stent Placement for artery blockage
|
0.00%
0/4 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/3 • Adverse event data include events starting on day 0 and ending at month 24.
|
6.7%
1/15 • Number of events 1 • Adverse event data include events starting on day 0 and ending at month 24.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Adverse event data include events starting on day 0 and ending at month 24.
|
33.3%
1/3 • Number of events 1 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/15 • Adverse event data include events starting on day 0 and ending at month 24.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
25.0%
1/4 • Number of events 1 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/3 • Adverse event data include events starting on day 0 and ending at month 24.
|
0.00%
0/15 • Adverse event data include events starting on day 0 and ending at month 24.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place