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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Retina Associates, PA
Shawnee Mission, Kansas, United States
RECRUITINGTo 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
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