Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

Conditions

• Age-related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - 110 Years

Healthy Volunteers

Not accepted

Interventions

• Squalamine lactate ophthalmic solution, 0.2% — DRUG
  Squalamine lactate ophthalmic solution, 0.2%
• Placebo Ophthalmic solution — DRUG
  Placebo Ophthalmic solution
• ranibizumab — DRUG
  ranibizumab

Study Details

A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint

Key Dates

First listed

Apr 5, 2016

Start date

Apr 12, 2016

Status verified

Apr 2017

Primary completion

Dec 31, 2017

Completion

Dec 31, 2017

Study Design

Enrollment

230 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Squalamine solution, 0.2% BID
  Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks
• Placebo Comparator: Placebo solution BID
  Placebo ophthalmic solution BID + ranibizumab every 4 weeks

Primary Outcome Measure

Functional change in visual acuity [ Time Frame: 9 months ]

Locations (118)

Find similar trials in Mobile, AL

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