Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

Official title:

A Study of Safety, Functional and Anatomical Effect of Squalamine Lactate Ophthalmic Solution, 0.2% Administered Twice Daily in Subjects With Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02511613
• Other study ID #: OHR-1501
• Status: Withdrawn
• Phase: Phase 2
• First received: July 27, 2015
• Last updated: April 25, 2017
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2017
• Source: Ohr Pharmaceutical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Subjects with age-related macular degeneration who meet inclusion and exclusion criteria will be randomized to receive monthly intravitreal injections of ranibizumab (Lucentis®) with either Squalamine Lactate Ophthalmic solution 0.2% or placebo eye drops twice a day for 6 months. Subjects will be evaluated with clinical and imaging techniques.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

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

• 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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Squalamine Lactate Ophthalmic Solution, 0.2%
Squalamine Lactate Ophthalmic Solution, 0.2% administered BID
• Placebo Ophthalmic Solution
Placebo Ophthalmic Solution, administered BID
• ranibizumab
ranibizumab intravitreal injection

Locations

Country	Name	City	State
United States	Investigational Site	Beverly Hills	California
United States	Investigational Site	Hagerstown	Maryland
United States	Investigational Site	Houston	Texas
United States	Investigational Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ohr Pharmaceutical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on anatomy and function as assessed by retinal imaging and ETDRS BCVA in subjects with Age-Related Macular Degeneration		6 months