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Clinical Trial Details
Research Study Summary
Patients are needed to participate in a clinical research study evaluating Lucentis (ranibizumab) for the treatment of Proliferative Diabetic Retinopathy
Research Study 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.
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Both Male and Female
Both Male and Female ages 21 Years and up
Ability to provide written informed consent and comply with study assessments for the
full duration of the study
Age > 20 years
Best corrected visual acuity of 20/40 to 20/800 in the study eye
Very servere nonproliferative diabetic retinopathy (ETDRS level 53E) OR moderate
proliferative diabetic retinopathy (ETDRS level 65)
Visual reduction attributable to diabetic vitreous hemorrhage or diabetic macular
Candidate for vitrectomy procedure
Pregnancy (positive Pregnancy test) or lactation
Premenopausal women not using adequate contraception. The following are considered
effective means of contraception: surgical sterilization or use of oral
contraceptives, barrier contraception with either a condom or diaphragm in
conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated.
Participation in another simultaneous medical investigation or trial.
Visual impairment attributable to causes other than diabetic macular edema or
diabetic vitreous hemorrhage.
Use of intraocular or periocular corticosteroids within 6 months.
History of panretinal photocoagulation
History of macular laser photocoagulation
History of pars plana vitrectomy
Prior or concomitant treatment with ranibizumab, bevacizumab, or pegaptanib sodium,
either as part of an investigational study or as an off-label medication.
Current treatment of a systemic infection
Site Locations (1)
||Retina Associates, PA
Gregory M Fox, MD
NCT ID: NCT00516464
Date Last Changed: August 14, 2007
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