Age-related Macular Degeneration Clinical Trial
Official title:
OHR-1601: A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint
Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2%
Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration Methodology: Phase
III, multicenter, randomized, double-masked, placebo-controlled study conducted over 9
months
(Screening/Baseline to Week 36): Patients will be randomly assigned to one of 2 treatment
groups in a 1:1 ratio:
- Squalamine lactate ophthalmic solution, 0.2% BID + ranibizumab every 4 weeks
- Placebo ophthalmic solution BID + monthly ranibizumab every 4 weeks
;
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