Clinical Trial: Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing

Study Status: Withdrawn
Recruit Status: Withdrawn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

Official Title: Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard AntiVEGF Dosing

Brief Summary: The investigators would like to investigate the efficacy of more frequent treatment with Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen.

Detailed Summary: This is an open-label, subject masked, phase II study of intravitreally administered ranibizumab in subjects with persistent diabetic macular edema. Persistent diabetic macular edema is defined as subjects who still have central subfield thickness on SD-OCT of greater than 320 microns after having received at least 3 previous doses of AntiVEGF therapy in the past 5 months. Consented, enrolled subjects will be randomized into two subgroups: (1) standard dosing of monthly 0.3mg ranibizumab or (2) 0.3mg ranibizumab given 2 weeks apart for 5 doses followed by monthly dosing.
Sponsor: Maturi, Raj K., M.D., P.C.

Current Primary Outcome: mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization [ Time Frame: 24 weeks ]

mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

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

Dates:
Date Received: April 29, 2014
Date Started:
Date Completion: November 2015
Last Updated: July 29, 2014
Last Verified: July 2014