Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion

Sponsor
Ohr Pharmaceutical Inc.
Study ID
NCT02614937
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Eligibility Criteria

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

Interventions

  • ranibizumab — DRUG
    0.5 mg IVT ranibizumab
  • Squalamine Lactate Ophthalmic Solution, 0.2% — DRUG
    Squalamine Lactate Ophthalmic Solution BID

Study Details

This was a prospective, single center, open label, randomized study evaluating the biological effect of squalamine lactate ophthalmic solution, 0.2% combined with intravitreous ranibizumab in patients with macular edema secondary to branch, hemi-central and central retinal vein occlusion (BRVO, HRVO, CRVO).

Key Dates

First listed
Nov 25, 2015
Start date
Apr 30, 2013
Status verified
Nov 2015
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Squalamine and ranibizumab to Week 10
    All eyes received an initial 10 week mandatory loading period of topical Squalamine Lactate Ophthalmic Solution, 0.2% therapy. All eyes received mandatory intravitreal injections of ranibizumab 0.5mg at the conclusions of weeks 2 and 6. Randomize at Week 10 to 2 different groups - Squalamine and No Squalamine, continue PRN ranibizumab in both groups
  • Experimental: Continue Squalamine, ranibizumab PRN
    Continue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
  • Experimental: Stop Squalamine, ranibizumab PRN
    Discontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN

Primary Outcome Measure

Visual Function - Efficacy [ Time Frame: Baseline to Week 38 ]

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