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Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

Primary Purpose

Macular Edema

Status

Unknown status

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

bevacizumab

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Intravitreal injection of Bevacizumab, Visual acuity, central retinal thickness, color studies, Farnsworth-Munsell, electroretinogram studies

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with proliferative diabetic retinopathy
patients with macular edema

Exclusion Criteria:

patients with previous treatments
patients with ocular surgeries

Sites / Locations

Asociación para Evitar la Ceguera en MéxicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

Bevacizumab before panretinal photocoagulation.

Bevacizumab after panretinal photocoagulation

Outcomes

Primary Outcome Measures

Central macular thickness

Secondary Outcome Measures

Best corrected visual acuity

Full Information

NCT ID

NCT00804206

First Posted

December 3, 2008

Last Updated

December 5, 2008

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00804206

Brief Title

Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

Official Title

Phase 4 Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Unknown status

Study Start Date

July 2008 (undefined)

Primary Completion Date

July 2008 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

5. Study Description

Brief Summary

Compare the effect of an intravitreal injection of bevacizumab previous or posterior of panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Edema

Keywords

Intravitreal injection of Bevacizumab, Visual acuity, central retinal thickness, color studies, Farnsworth-Munsell, electroretinogram studies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Bevacizumab before panretinal photocoagulation.

Arm Title

Group B

Arm Type

Experimental

Arm Description

Bevacizumab after panretinal photocoagulation

Intervention Type

Drug

Intervention Name(s)

bevacizumab

Intervention Description

Intravitreal bevacizumab before panretinal photocoagulation

Intervention Type

Drug

Intervention Name(s)

bevacizumab

Intervention Description

Intravitreal Bevacizumab after panretinal photocoagulation

Primary Outcome Measure Information:

Title

Central macular thickness

Time Frame

baseline, 10 days, 52 days, 85 days

Secondary Outcome Measure Information:

Title

Best corrected visual acuity

Time Frame

baseline, 10 days, 52 days, 85 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with proliferative diabetic retinopathy patients with macular edema Exclusion Criteria: patients with previous treatments patients with ocular surgeries

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miriam Jessica López-Miranda, MD

Phone

10841400

Ext

1171

jessicalop@hotmail.com

Facility Information:

Facility Name

Asociación para Evitar la Ceguera en México

City

México

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miriam Jessica López-Miranda, MD

Phone

10841400

Ext

1171

jessicalop@hotmail.com

First Name & Middle Initial & Last Name & Degree

Fernando Hernandez-Miranda, MD

First Name & Middle Initial & Last Name & Degree

Miriam Jessica López-Miranda, MD

First Name & Middle Initial & Last Name & Degree

José Luis Guerrero-Naranjo, MD

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

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