Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema (DME)

• Status: Withdrawn
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. The study duration is 52 weeks and patients will be randomized to one of four treatment arms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Starr Muscle
• Collaborator: Ohr Pharmaceutical Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Ranibizumab; Squalamine; Tetrahydrozoline

Criteria

Inclusion Criteria:

• Subjects will have clinically significant diabetic macular edema of ≥ 300 microns with central involvement using the Heidelberg or Cirrus machine

• Best corrected visual acuity of 20/32 to 20/320 inclusive in the study eye

• Adults ≥ 18 years of age with type 1 or 2 diabetes mellitus with diabetic macular edema

Exclusion Criteria:

• History of vitreoretinal surgery in the study eye

• Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening

• Any prior laser in study eye

• Previous use of intraocular or periocular corticosteroids in the study eye within 6 months of screening

• Previous treatment with anti-angiogenic drugs in either eye within 3 months of screening

• Uncontrolled diabetes mellitus with HbA1c levels greater than 12

• Ocular disorders in the study eye, other than diabetic macular edema, that my confound interpretation of study results