NCT02727881

Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Ohr Pharmaceutical Inc. · Industry
• Sex: All
• Age: 50 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Squalamine lactate ophthalmic solution, 0.2%	Squalamine lactate ophthalmic solution, 0.2%
DRUG	Placebo Ophthalmic solution	Placebo Ophthalmic solution
DRUG	ranibizumab	ranibizumab

Timeline

• Start date: 2016-04-12
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-04-05
• Last updated: 2017-04-27

Locations

118 sites across 1 country: United States