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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Improvements in BCVA ETDRS [ Time Frame: 6 months ]
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