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

Sponsor

Ohr Pharmaceutical Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02511613

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Drug: Squalamine Lactate Ophthalmic Solution, 0.2% Drug: Placebo Ophthalmic Solution Drug: ranibizumab	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2016

Anticipated Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution	Drug: Placebo Ophthalmic Solution Placebo Ophthalmic Solution, administered BID Other Names: Placebo Drug: ranibizumab ranibizumab intravitreal injection Other Names: Lucentis®
Active Comparator: Active Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%	Drug: Squalamine Lactate Ophthalmic Solution, 0.2% Squalamine Lactate Ophthalmic Solution, 0.2% administered BID Other Names: Squalamine Drug: ranibizumab ranibizumab intravitreal injection Other Names: Lucentis®

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution

Drug: Placebo Ophthalmic Solution

Placebo Ophthalmic Solution, administered BID

Other Names:

Placebo

Drug: ranibizumab

ranibizumab intravitreal injection

Other Names:

Lucentis®

Active Comparator: Active

Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%

Drug: Squalamine Lactate Ophthalmic Solution, 0.2%

Squalamine Lactate Ophthalmic Solution, 0.2% administered BID

Other Names:

Squalamine

Drug: ranibizumab

ranibizumab intravitreal injection

Other Names:

Lucentis®

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Beverly Hills	California	United States	90211
2	Investigational Site	Hagerstown	Maryland	United States	21740
3	Investigational Site	New York	New York	United States	10022
4	Investigational Site	Houston	Texas	United States	77030