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Research & Clinical Trials

Study Detail: DRCR N

Trial Description Summary The study is being conducted to determine if intravitreal injections of ranibizumab decrease the proportion of eyes in which vitrectomy is performed compared with saline injections in eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.


Basic Trial Information

Disease under study: Vitreous hemorrhage due to PDR
Age: 18 or older
Sponsor: National Institue of Health (NIH)
Protocol #: DRCR
Study Duration: 52 weeks


OPHTHALMIC INCLUSION
*Vitreal hemorrhage causing vision impairment, presumed to be from PDR and precluding completion of PRP (or precluding assessment of completeness of prior PRP) A prior full session of PRP is permitted provided that the *VH precludes assessment of the completeness of the prior treatment on clinical exam.
*Immediate vitrectomy not required for at least 8 weeks
*Visual acuity is light perception or better
*Other inclusion criteria per protocol
GENERAL OPHTHALMIC EXCLUSION
*Need for immediate vitrectomy due to Rhegmatogenous RD or traction detachment involving the macula present on ultrasound
*Exam evidence of NVG, Angle NV or active NVI (small iris tufts not an exclusion)
*History of intravitreal anti-VEGF TX for VH at any time in the past or for an indication other than VH in the past 2 months
*History of vitrectomy
*Other exclusion criteria per protocol
GENERAL MEDICAL EXCLUSION
*MI, stroke, TIA, cardiac event requiring hospitalization, or acute CHF within 4months  prior to randomization.
*Other criteria per protocol

Study Title
An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage due to Proliferative Diabetic Retinopathy

Trial Contact Information
Site Study Coordinator
Beachwood 216/831-5700 x 253
Middleburg Hts. 216/831-5704 x 253