Avastin for Post-photocoagulation Macular Edema

May 29, 2024 updated by: Asociación para Evitar la Ceguera en México

Prevention of Post-photocoagulation Macular Edema by Intravitreal Bevacizumab.

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico, DF, Mexico, 04030
        • Asociación Para Evitar la Ceguera en México

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Panretinal Photocoagulation + Bevacizumab
Drug: Bevacizumab
Intravitreal administration
Experimental: Group 2
Panretinal Photocoagulation
Procedure: Panretinal Photocoagulation
Panretinal Photocoagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Best Corrected Visual Acuity

Secondary Outcome Measures

Outcome Measure
Central Retinal Thickness.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Study Director: Eduarto Torres-Porras, MD, Asociación Para Evitar la Ceguera en México
  • Principal Investigator: Octavio Burgos, MD, Asociación Para Evitar la Ceguera en México

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (Estimated)

December 4, 2008

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APEC-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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