Trials / Withdrawn
WithdrawnNCT02511613
Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration
A Study of Safety, Functional and Anatomical Effect of Squalamine Lactate Ophthalmic Solution, 0.2% Administered Twice Daily in Subjects With Neovascular Age-related Macular Degeneration
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Ohr Pharmaceutical Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.
Detailed description
Subjects with age-related macular degeneration who meet inclusion and exclusion criteria will be randomized to receive monthly intravitreal injections of ranibizumab (Lucentis®) with either Squalamine Lactate Ophthalmic solution 0.2% or placebo eye drops twice a day for 6 months. Subjects will be evaluated with clinical and imaging techniques.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Squalamine Lactate Ophthalmic Solution, 0.2% | Squalamine Lactate Ophthalmic Solution, 0.2% administered BID |
| DRUG | Placebo Ophthalmic Solution | Placebo Ophthalmic Solution, administered BID |
| DRUG | ranibizumab | ranibizumab intravitreal injection |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2015-07-30
- Last updated
- 2017-04-27
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02511613. Inclusion in this directory is not an endorsement.