A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 11/30/2018 |
| Start Date: | November 6, 2017 |
| End Date: | March 2020 |
A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)
A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging
study, investigating two doses of OPT-302 in combination with ranibizumab compared with
ranibizumab with sham, over six consecutive monthly dosing cycles in participants with
neovascular (wet) AMD.
study, investigating two doses of OPT-302 in combination with ranibizumab compared with
ranibizumab with sham, over six consecutive monthly dosing cycles in participants with
neovascular (wet) AMD.
Inclusion Criteria:
- Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to
age-related macular AMD
- An ETDRS BCVA score between 60 and 25 (inclusive) letters
Exclusion Criteria:
- Previous treatment for wet AMD or previous treatment for CNV due to other causes in
the Study Eye
- Clinically significant ocular disorders which may interfere with assessment of visual
acuity, assessment of toxicity, or fundus photography in the Study Eye
- Poorly controlled diabetes mellitus (defined as HbA1c>7%)
- Any clinically significant cardiovascular, renal or hepatic conditions, recent
surgery, or malignancy, that would make the participant unsuitable for the study
We found this trial at
51
sites
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