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

Asociación para Evitar la Ceguera en México

Status and phase: Withdrawn; Phase 3

Conditions: Diffuse Diabetic Macular Edema

Treatments: Drug: Triamcinolone Acetonide and Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00600301

APEC-OO13

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)