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

Ohr Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Age-related Macular Degeneration

Treatments: Drug: Squalamine lactate ophthalmic solution, 0.2%; Drug: ranibizumab; Drug: Placebo Ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02727881

OHR-1601

Details and patient eligibility

About

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

Full 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

Enrollment: 230 patients

Sex: All

Ages: 50 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

230 participants in 2 patient groups, including a placebo group

Squalamine solution, 0.2% BID

Experimental group

Description:

Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks

Treatment:

Drug: ranibizumab

Drug: Squalamine lactate ophthalmic solution, 0.2%

Placebo solution BID

Placebo Comparator group

Description:

Placebo ophthalmic solution BID + ranibizumab every 4 weeks

Treatment:

Drug: Placebo Ophthalmic solution

Drug: ranibizumab