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A Randomized, Controlled Study of the Safety and Efficacy of Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema
A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. The study duration is 52 weeks and patients will be randomized to one of four treatment arms.
Details
| Lead sponsor | Starr Muscle |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2015-02 |
| Completion | 2015-09 |
Conditions
- Diabetic Retinopathy
Interventions
- Squalamine Lactate Ophthalmic Solution 0.2%
Primary outcomes
- To explore the effect of Squalamine Lactate eye drops on Best Corrected Visual Acuity in subjects with diabetic macular edema — Mean change from baseline to Week 24
Proportion of patients gaining at least 3,4 and 5 lines in best corrected visual acuity from baseline to week 24
Countries
United States