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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diffuse Diabetic Macular Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Triamcinolone Acetonide and Bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No