Trial Outcomes & Findings for A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema (NCT NCT03397264)
NCT ID: NCT03397264
Last Updated: 2025-04-22
Results Overview
Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2025-04-22
Participant Flow
Participant milestones
| Measure |
Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With Sham
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Aflibercept: Intravitreal injection
Sham intravitreal injection: Sham (mock) intravitreal injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
96
|
48
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
89
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
7
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ph1b and Ph2a studies were two separate studies within the one protocol. Combined mean age across the two studies was not calculated.
Baseline characteristics by cohort
| Measure |
Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=96 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With Sham
n=48 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Aflibercept: Intravitreal injection
Sham intravitreal injection: Sham (mock) intravitreal injection
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=153 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
58 Participants
n=96 Participants
|
32 Participants
n=48 Participants
|
96 Participants
n=153 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
38 Participants
n=96 Participants
|
16 Participants
n=48 Participants
|
57 Participants
n=153 Participants
|
|
Age, Continuous
Ph 1b
|
59.0 years
STANDARD_DEVIATION 6.24 • n=3 Participants • Ph1b and Ph2a studies were two separate studies within the one protocol. Combined mean age across the two studies was not calculated.
|
68.7 years
STANDARD_DEVIATION 7.51 • n=3 Participants • Ph1b and Ph2a studies were two separate studies within the one protocol. Combined mean age across the two studies was not calculated.
|
55.7 years
STANDARD_DEVIATION 7.02 • n=3 Participants • Ph1b and Ph2a studies were two separate studies within the one protocol. Combined mean age across the two studies was not calculated.
|
—
|
—
|
61.1 years
STANDARD_DEVIATION 8.39 • n=9 Participants • Ph1b and Ph2a studies were two separate studies within the one protocol. Combined mean age across the two studies was not calculated.
|
|
Age, Continuous
Ph 2a
|
—
|
—
|
—
|
61.8 years
STANDARD_DEVIATION 10.07 • n=96 Participants • Ph1b and Ph2a studies were two separate studies within the one protocol. Combined mean age across the two studies was not calculated.
|
61.2 years
STANDARD_DEVIATION 9.40 • n=48 Participants • Ph1b and Ph2a studies were two separate studies within the one protocol. Combined mean age across the two studies was not calculated.
|
61.6 years
STANDARD_DEVIATION 9.93 • n=144 Participants • Ph1b and Ph2a studies were two separate studies within the one protocol. Combined mean age across the two studies was not calculated.
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
36 Participants
n=96 Participants
|
18 Participants
n=48 Participants
|
56 Participants
n=153 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
60 Participants
n=96 Participants
|
30 Participants
n=48 Participants
|
97 Participants
n=153 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=96 Participants
|
1 Participants
n=48 Participants
|
2 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
8 Participants
n=96 Participants
|
8 Participants
n=48 Participants
|
17 Participants
n=153 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
87 Participants
n=96 Participants
|
37 Participants
n=48 Participants
|
132 Participants
n=153 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=96 Participants
|
2 Participants
n=48 Participants
|
2 Participants
n=153 Participants
|
|
Region of Enrollment
Latvia
|
0 participants
n=3 Participants
|
0 participants
n=3 Participants
|
0 participants
n=3 Participants
|
6 participants
n=96 Participants
|
3 participants
n=48 Participants
|
9 participants
n=153 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
61 participants
n=96 Participants
|
31 participants
n=48 Participants
|
92 participants
n=153 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=3 Participants
|
0 participants
n=3 Participants
|
0 participants
n=3 Participants
|
24 participants
n=96 Participants
|
10 participants
n=48 Participants
|
34 participants
n=153 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=3 Participants
|
0 participants
n=3 Participants
|
0 participants
n=3 Participants
|
5 participants
n=96 Participants
|
4 participants
n=48 Participants
|
9 participants
n=153 Participants
|
|
Baseline ETDRS Best Corrected Visual Acuity
|
64.3 Letters read
STANDARD_DEVIATION 7.02 • n=3 Participants
|
64.7 Letters read
STANDARD_DEVIATION 1.53 • n=3 Participants
|
66.0 Letters read
STANDARD_DEVIATION 8.89 • n=3 Participants
|
63.3 Letters read
STANDARD_DEVIATION 8.31 • n=96 Participants
|
63.9 Letters read
STANDARD_DEVIATION 9.44 • n=48 Participants
|
63.5 Letters read
STANDARD_DEVIATION 8.68 • n=153 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Safety Population; Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analyzed as part of the sham combination for the safety analysis only.
Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)
Outcome measures
| Measure |
Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=95 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With Sham
n=49 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Aflibercept: Intravitreal injection
Sham intravitreal injection: Sham (mock) intravitreal injection
|
|---|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Treatment Emergent AE to Wk 12
|
3 Participants
|
2 Participants
|
1 Participants
|
59 Participants
|
28 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Ocular Treatment Emergent AEs to Wk 12
|
2 Participants
|
2 Participants
|
1 Participants
|
43 Participants
|
16 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Non-ocular Treatment Emergnt AEs to Wk 12
|
2 Participants
|
2 Participants
|
0 Participants
|
35 Participants
|
17 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Non Ocular SAEs to Wk 12
|
1 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
1 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Ocular SAEs to Wk 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Primary Analysis (pre-specified) OPT-302 combination therapy will be considered to have clinical activity if \>= 27 of 72 participants have a \>= 5 letters gain in BCVA from baseline to week 12. The combination therapy will be considered to have insufficient clinical activity if \<= 25 of 72 participants have a \>= 5 letters gain in BCVA from baseline to week 12.
Change from baseline in Best Corrected Visual Acuity (BCVA) will be measured at Week 12 according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria
Outcome measures
| Measure |
Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302
n=72 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With Sham
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Aflibercept: Intravitreal injection
Sham intravitreal injection: Sham (mock) intravitreal injection
|
|---|---|---|---|---|---|
|
Phase 2a: Response Rate Defined as Proportion of Participants Receiving OPT-302 With Aflibercept Achieving at Least a 5-letter Gain in BCVA at Week 12
|
38 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Per Protocol Population
Mean change in Best Corrected Visual Acuity (BCVA). BCVA will be measured according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria
Outcome measures
| Measure |
Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=75 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With Sham
n=40 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Aflibercept: Intravitreal injection
Sham intravitreal injection: Sham (mock) intravitreal injection
|
|---|---|---|---|---|---|
|
Mean Change in BCVA
|
3.0 Letters
Standard Error 2.52
|
5.7 Letters
Standard Error 1.20
|
14.3 Letters
Standard Error 5.46
|
5.9 Letters
Standard Error 0.79
|
6.1 Letters
Standard Error 0.96
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Per Protocol Population; and where CST measurements at Week 12 were available to assess the endpoint.
Mean change in central subfield thickness (CST) on spectral domain coherence tomography (SD-OCT)
Outcome measures
| Measure |
Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=3 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=74 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With Sham
n=39 Participants
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Aflibercept: Intravitreal injection
Sham intravitreal injection: Sham (mock) intravitreal injection
|
|---|---|---|---|---|---|
|
Mean Change in CST
|
-116.0 µm
Standard Error 46.12
|
-41.0 µm
Standard Error 28.88
|
-57.0 µm
Standard Error 12.86
|
-52.2 µm
Standard Error 10.28
|
-34.9 µm
Standard Error 12.01
|
Adverse Events
Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302
Serious events: 8 serious events
Other events: 36 other events
Deaths: 0 deaths
Ph 2a: 2.0 mg Aflibercept With Sham
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302
n=3 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302
n=3 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=3 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=95 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With Sham
n=49 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Aflibercept: Intravitreal injection
Sham intravitreal injection: Sham (mock) intravitreal injection
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
2.1%
2/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
2.0%
1/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Renal and urinary disorders
Nephrolithiasis
|
33.3%
1/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
33.3%
1/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
General disorders
Ulcer
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
1.1%
1/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Eye disorders
Ocular SAE
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
Other adverse events
| Measure |
Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302
n=3 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302
n=3 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=3 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302
n=95 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Aflibercept: Intravitreal injection
OPT-302: Intravitreal Injection
|
Ph 2a: 2.0 mg Aflibercept With Sham
n=49 participants at risk
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Aflibercept: Intravitreal injection
Sham intravitreal injection: Sham (mock) intravitreal injection
|
|---|---|---|---|---|---|
|
Eye disorders
Conjunctival Haemorrhage
|
33.3%
1/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
33.3%
1/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
33.3%
1/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
20.0%
19/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
12.2%
6/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Eye disorders
Intraocular Pressure Increased
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
13.7%
13/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
6.1%
3/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Eye disorders
Punctate Keratitis
|
33.3%
1/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
2.1%
2/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
6.1%
3/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
0.00%
0/3 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
2.1%
2/95 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
6.1%
3/49 • Baseline to Week 12
Ph2a: One participant assigned 2.0 mg OPT-302 with aflibercept did not receive OPT-302 therefore this participant was analysed as part of the sham combination for the safety analysis only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator may publish data or results from the Study; provided the Principal Investigator submits the proposed publication to Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary and/or commercially sensitive to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER