56
Participants
Start Date
May 31, 2012
Primary Completion Date
February 28, 2015
Study Completion Date
February 28, 2015
Ranibizumab
"Series of three intravitreous injections of ranibizumab (0.3 mg)\* or bevacizumab (1.25 mg) administered every 4 weeks for three 12-week periods. Following this crossover phase, eyes received ranibizumab or bevacizumab to which they were originally assigned and treated on an as-needed basis until study completion.~\*Eleven doses of ranibizumab 0.5 mg were given to participants at the start of the study; after FDA approval of the 0.3 mg dose for DME, the protocol was amended and 0.3 mg was used for the remainder of the study (98% of all injections)."
Bevacizumab
"Series of three intravitreous injections of ranibizumab (0.3 mg)\* or bevacizumab (1.25 mg) administered every 4 weeks for three 12-week periods. Following this crossover phase, eyes received ranibizumab or bevacizumab to which they were originally assigned and treated on an as-needed basis until study completion.~\*Eleven doses of ranibizumab 0.5 mg were given to participants at the start of the study; after FDA approval of the 0.3 mg dose for DME, the protocol was amended and 0.3 mg was used for the remainder of the study (98% of all injections)."
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
Bristol Eye Hospital, Bristol
The Emmes Company, LLC
INDUSTRY
National Eye Institute (NEI)
NIH