Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

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WITHDRAWN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

2005-09-30

Study Completion Date

2006-05-31

Brief Summary

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Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema

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Detailed Description

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A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.

Conditions

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Diabetes Mellitus Type 2 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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Intravitreal Bevacizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Macular edema involving the center of the macula demonstrated on OCT
* Clear ocular media
* Untreated patients
* Older than 45 years
* BCVA of the fellow eye at least 20/100

Exclusion Criteria

* Renal diabetic disease, uncontrolled hypertension or stroke history
* Other ocular disease
* Ocular surgery excepting uncomplicated phacoemulsification
* History of photocoagulation (panretinal or focal)
* History of another intravitreal treatment (like triamcinolone)

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No