NCT00516464

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

Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Retina Associates, Kansas City · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Lucentis (ranibizumab)

Timeline

• Start date: 2007-08-01
• Completion: 2008-08-01
• First posted: 2007-08-15
• Last updated: 2007-08-15

Locations

1 site across 1 country: United States