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

NCT02727881 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2017-04-27

No results posted yet for this study

Summary

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

Conditions

  • Age-related Macular Degeneration

Interventions

DRUG

Squalamine lactate ophthalmic solution, 0.2%

Squalamine lactate ophthalmic solution, 0.2%

DRUG

Placebo Ophthalmic solution

Placebo Ophthalmic solution

DRUG

ranibizumab

ranibizumab

Sponsors & Collaborators

  • Ohr Pharmaceutical Inc.

    lead INDUSTRY

Principal Investigators

  • Avner Ingerman, MD · Ohr Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-12
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02727881 on ClinicalTrials.gov