Clinical Trial: Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Ed

Brief Summary: The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.

Detailed Summary:
Sponsor: Maturi, Raj K., M.D., P.C.

Current Primary Outcome:

• Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline [ Time Frame: baseline to 12 month ]
  Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
• OCT CST [ Time Frame: change in OCT CST from baseline to twelve months ]
  change in optical coherence tomography central subfield thickness

Original Primary Outcome: BCVA measured using ETDRS methodology at month 12 compared to baseline [ Time Frame: 12 month ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Maturi, Raj K., M.D., P.C.

Dates:
Date Received: March 3, 2011
Date Started: March 2011
Date Completion:
Last Updated: October 28, 2014
Last Verified: October 2014