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Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

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

NCT02511613•Ohr Pharmaceutical Inc.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (4)

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

Key Dates

Start Date

July 1, 2015

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

April 27, 2017

Conditions

Age-Related Macular Degeneration

Interventions

Squalamine Lactate Ophthalmic Solution, 0.2%

DRUG

Placebo Ophthalmic Solution

DRUG

ranibizumab

DRUG

Direct Discrimination of Quantum States by the Human Eye

NCT05913063

Age-Related Macular Degeneration

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NCT06990269

Geographic Atrophy Secondary to Age-related Macular Degeneration

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A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Direct Discrimination of Quantum States by the Human Eye

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)