Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

NCT ID: NCT00571142

Last Updated: 2024-05-31

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-02-29

Brief Summary

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To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease.

Detailed Description

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Conditions

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Diffuse Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Renal disease

Group Type ACTIVE_COMPARATOR

Bevacizumab + Pars plana vitrectomy

Intervention Type PROCEDURE

2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.

2

Without renal disease

Group Type ACTIVE_COMPARATOR

Bevacizumab + pars plana vitrectomy

Intervention Type PROCEDURE

2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy

Interventions

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Bevacizumab + Pars plana vitrectomy

2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.

Intervention Type PROCEDURE

Bevacizumab + pars plana vitrectomy

2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Older than 25 yo
* Diffuse diabetic macular edema with or without previous treatment

Exclusion Criteria

* Another retinal disease
* Pregnancy
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role lead

Responsible Party

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Asociacion para Evitar la Ceguera en Mexico I.A.P.

Principal Investigators

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Veronica Kon-Jara, MD

Role: PRINCIPAL_INVESTIGATOR

Asociación para Evitar la Ceguera en México

Locations

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Asociacion para Evitar la Ceguera en Mexico I.A.P.

México, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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APEC-ret

Identifier Type: -

Identifier Source: org_study_id

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