search
Back to results

Avastin for Post-Photocoagulation Macular Edema

Primary Purpose

Macular Edema

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Bevacizumab
Panretinal Photocoagulation
Sponsored by
Asociación para Evitar la Ceguera en México
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Panretinal Photocoagulation, Macular Edema, Intravitreal Bevacizumab

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Proliferative retinopathy or severe non-proliferative retinopathy
  • BCVA of 20/63 or better (56 ETDRS letters
  • No history of Macular Edema
  • Central Retinal Thickness of 250mics or more

Exclusion Criteria:

  • Previous treatment.
  • Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy
  • Media opacities

Sites / Locations

  • Asociación para Evitar la Ceguera en México

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Panretinal Photocoagulation + Bevacizumab

Panretinal Photocoagulation

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity

Secondary Outcome Measures

Central Retinal Thickness.

Full Information

First Posted
December 3, 2008
Last Updated
December 3, 2008
Sponsor
Asociación para Evitar la Ceguera en México
search

1. Study Identification

Unique Protocol Identification Number
NCT00801866
Brief Title
Avastin for Post-Photocoagulation Macular Edema
Official Title
Prevention of Post-Photocoagulation Macular Edema by Intravitreal Bevacizumab.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Asociación para Evitar la Ceguera en México

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
Keywords
Panretinal Photocoagulation, Macular Edema, Intravitreal Bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Panretinal Photocoagulation + Bevacizumab
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Panretinal Photocoagulation
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Intravitreal administration
Intervention Type
Procedure
Intervention Name(s)
Panretinal Photocoagulation
Intervention Description
Panretinal Photocoagulation
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Secondary Outcome Measure Information:
Title
Central Retinal Thickness.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Proliferative retinopathy or severe non-proliferative retinopathy BCVA of 20/63 or better (56 ETDRS letters No history of Macular Edema Central Retinal Thickness of 250mics or more Exclusion Criteria: Previous treatment. Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy Media opacities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduarto Torres-Porras, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Octavio Burgos, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociación para Evitar la Ceguera en México
City
Mexico
State/Province
DF
ZIP/Postal Code
04030
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Avastin for Post-Photocoagulation Macular Edema

We'll reach out to this number within 24 hrs