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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
ranibizumab 0.3mg intravitreally monthly
ranibizumab given every 2 weeks for 8 weeks then monthly as needed
Raj K Maturi MD
Indianapolis, Indiana, United States
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization
Time frame: 24 weeks
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