Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

Phase 3

Withdrawn

• Conditions: Diffuse Diabetic Macular Edema

• Registration Number: NCT00600301
• Lead Sponsor: Asociación para Evitar la Ceguera en México

Brief Summary

Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-30
• Study Start: 2008-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-01-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diffuse diabetic macular edema
• Non proliferative diabetic retinopathy
• No VPP previa
• No previous treament with laser, Triamcinolone acetonide, and Bevacizumab

Exclusion Criteria

• Proliferative diabetic retinopathy
• Previous pars plana vitrectomy
• Previous treatment with diabetic macular edema
• Focal macular edema
• Macular Ischemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Asociacion Para Evitar la Ceguera en Mexico; 🇲🇽 Mexico, Mexico