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

Diffuse Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00600301
• Other study ID #: APEC-OO13
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2008
• Est. completion date: January 2008

Study information

• Verified date: May 2024
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Triamcinolone Acetonide and Bevacizumab

Locations

Country	Name	City	State
Mexico	Asociacion Para Evitar la Ceguera en Mexico	Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico,