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

Phase 3

• Conditions: Proliferative Diabetic Retinopathy

• Registration Number: NCT00516464
• Lead Sponsor: Retina Associates, Kansas City

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2007-08
• Study Start: 2007-08
• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Last Update Submitted: 2007-08-14
• Study First Posted: 2007-08-15
• Last Update Posted: 2007-08-15
• Study Completion: 2008-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of ranibizumab on vitrectomy complications such as recurrent vitreous hemorrhage, postoperative retinal detachment rates, and development of intraoperative retinal breaks.	6 months

Trial Locations

Locations (1)

Retina Associates, PA; 🇺🇸 Shawnee Mission, Kansas, United States