Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
Recruitment status was Recruiting
Evaluation of ranibizumab on the ease and procedure and complication in proliferative diabetic retinopathy (PDR) requiring vitrectomy.
Proliferative Diabetic Retinopathy
Drug: Lucentis (ranibizumab)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy|
- To evaluate the effect of ranibizumab on vitrectomy complications such as recurrent vitreous hemorrhage, postoperative retinal detachment rates, and development of intraoperative retinal breaks. [ Time Frame: 6 months ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||August 2008|
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.
|United States, Kansas|
|Retina Associates, PA||Recruiting|
|Shawnee Mission, Kansas, United States, 66204|
|Contact: Lexie Manning 913-831-7400 firstname.lastname@example.org|
|Principal Investigator: Gregory M Fox, MD|
|Principal Investigator:||Gregory M Fox, MD||Retina Associates, PA|