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

Withdrawn before enrolling · Phase 2

Conditions studied: Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT02349516

Run by

Starr Muscle

People needed

0

Starts

2015-02-01

Expected to finish

2015-09-01

Last updated by the study team

2016-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NJ Retina — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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