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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02127684
Study type Interventional
Source Maturi, Raj K., M.D., P.C.
Contact
Status Withdrawn
Phase Phase 2
Completion date November 2015