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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Ohr Pharmaceutical Inc.
Study ID
NCT02511613
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Squalamine Lactate Ophthalmic Solution, 0.2% — DRUG
    Squalamine Lactate Ophthalmic Solution, 0.2% administered BID
  • Placebo Ophthalmic Solution — DRUG
    Placebo Ophthalmic Solution, administered BID
  • ranibizumab — DRUG
    ranibizumab intravitreal injection

Study Details

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.

Key Dates

First listed
Jul 30, 2015
Start date
Jul 31, 2015
Status verified
Apr 2017
Primary completion
Apr 30, 2016
Completion
Apr 30, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution
  • Active Comparator: Active
    Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%

Primary Outcome Measure

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 [ Time Frame: 6 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Investigational SiteBeverly HillsCalifornia90211-
Investigational SiteHagerstownMaryland21740-
Investigational SiteNew YorkNew York10022-
Investigational SiteHoustonTexas77030-

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