Age-related Macular Degeneration
Conditions
Keywords
AMD, CNV, choroidal neovascularization, retinal eye disease
Brief 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
Interventions
Squalamine lactate ophthalmic solution, 0.2%
DRUGPlacebo Ophthalmic solution
Placebo Ophthalmic solution
DRUGranibizumab
ranibizumab
Sponsors
Ohr Pharmaceutical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 50 years * A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA) * Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm * Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study \[ETDRS\] chart)
Exclusion criteria
* 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 * Pigment epithelial detachment (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional change in visual acuity | 9 months | Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional changes in visual acuity | 9 months | Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent Adverse Event (AE) monitoring | 9 months | Adverse and Serious Adverse Events in subjects receiving combination therapy of ranibizumab intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% assessed by adverse event reporting and Ophthalmic examinations |
Countries
United States
Outcome results
None listed