Clinical Trial: Safety Study of ALG- 1001 to Treat Diabetic Macular Edema

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Safety Study of ALG 1001 to Treat Diabetic Macular Edema

Brief Summary: The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. The secondary endpoint of this study is observation of a clinical effect in BCVA (ETDRS letters) and OCT central macular thickness.

Detailed Summary: The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. The secondary endpoint of this study is observation of a clinical effect in best corrected visual acuity (BCVA) (ETDRS letters) and OCT central macular thickness.
Sponsor: Allegro Ophthalmics, LLC

Current Primary Outcome: Observation of dose limiting toxicity [ Time Frame: 6 months ]

The primary endpoint of this study is observation of dose limiting toxicity and the maximum tolerated dose. This determination will be made by the following criteria : Ocular Adverse Events by standard Clinical Ophthalmic examination Visual acuity changes from BCVA (ETDRS equivalent) at baseline by Slit Lamp Bio-microscopy, Tonometry, Indirect Ophthalmoscopy/ Fundus Photography, Fluorescein Angiography, OCT Central Macular Thickness, and ERG Examination


Original Primary Outcome: Same as current

Current Secondary Outcome: Improvements in BCVA ETDRS [ Time Frame: 6 months ]

Reduction in OCT central macular thickness in subjects with baseline diabetic macular edema and Improvements in BCVA ETDRS letters at 4 meters from baseline to 30 days, 60 days and 90 days post injection evaluations with safety evaluations to 180 days


Original Secondary Outcome: Same as current

Information By: Allegro Ophthalmics, LLC

Dates:
Date Received: November 28, 2011
Date Started: January 2011
Date Completion:
Last Updated: December 6, 2012
Last Verified: December 2012