Trials / Terminated
TerminatedNCT04757610
OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 986 (actual)
- Sponsor
- Opthea Limited · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 2.0 mg OPT-302 | intravitreal injection |
| BIOLOGICAL | 0.5 mg ranibizumab | intravitreal injection |
| PROCEDURE | Sham | intravitreal injection |
Timeline
- Start date
- 2021-03-12
- Primary completion
- 2025-03-31
- Completion
- 2025-03-31
- First posted
- 2021-02-17
- Last updated
- 2025-07-22
- Results posted
- 2025-07-22
Locations
191 sites across 24 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Latvia, Malaysia, Poland, South Korea, Spain, Thailand, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04757610. Inclusion in this directory is not an endorsement.