Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

• Status: Unknown status
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of ranibizumab on the ease and procedure and complication in proliferative diabetic retinopathy (PDR) requiring vitrectomy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Retina Associates, Kansas City
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• 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 edema

• Candidate for vitrectomy procedure

Exclusion Criteria:

• 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