Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
Evaluation of ranibizumab on the ease and procedure and complication in proliferative diabetic retinopathy (PDR) requiring vitrectomy.
This is an open-label, Phase I/II study of multiple doses of intravitreally administered
ranibizumab in patients with severe NPDR and PDR prior to, during, and after vitrectomy
therapy.
40 subjects will be enrolled and randomized 3:1 to ranibizumab or vitrectomy alone. 30
consented, enrolled subjects will receive 3 intravitreal injections of 0.5 mg ranibizumab
administered 1-3 weeks pre-procedure, intraoperatively, and 1 month post-vitrectomy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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