Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Age-Related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT02511613
- Run by
- Ohr Pharmaceutical Inc.
- People needed
- 0
- Starts
- 2015-07-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2017-04-27
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 50 years of age or older
- A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye
- Central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by Optical Coherence Tomography (OCT)
- Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 by Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol
You may not qualify if…
- Neovascularization secondary to any other condition than AMD in the study eye
- Blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea
- PED without associated subretinal fluid and/or cystic retinal changes
- Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
- Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
- Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
- Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye
Where it is running
- Investigational Site — Beverly Hills, California, United States
- Investigational Site — Hagerstown, Maryland, United States
- Investigational Site — New York, New York, United States
- Investigational Site — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.