Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02614937 | Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion | PHASE1 | COMPLETED | 20 | — | — | Apr 1, 2013 | Dec 1, 2014 | Nov 25, 2015 | - | — |
Mean change in ETDRS letter score from baseline
| Arm | Type | Description |
|---|---|---|
| Squalamine and ranibizumab to Week 10 | EXPERIMENTAL | All eyes received an initial 10 week mandatory loading period of topical Squalamine Lactate Ophthalmic Solution, 0.2% therapy. All eyes received mandatory intravitreal injections of ranibizumab 0.5mg at the conclusions of weeks 2 and 6. Randomize at Week 10 to 2 different groups - Squalamine and No Squalamine, continue PRN ranibizumab in both groups |
| Continue Squalamine, ranibizumab PRN | EXPERIMENTAL | Continue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN |
| Stop Squalamine, ranibizumab PRN | EXPERIMENTAL | Discontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN |
| Name | Type | Description |
|---|---|---|
| ranibizumab | DRUG | 0.5 mg IVT ranibizumab |
| Squalamine Lactate Ophthalmic Solution, 0.2% | DRUG | Squalamine Lactate Ophthalmic Solution BID |
Inclusion Criteria: * Eyes with treatment naïve, center involving macular edema secondary to BRVO, HRVO or CRVO in patients of at least 40 years of age * Macular edema of 1-4 months duration prior to the baseline visit * Best corrected baseline ETDRS visual acuity of 20/40 to 20/320 Snellen equival...