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

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

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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
      • México, 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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with proliferative diabetic retinopathy
  • patients with macular edema

Exclusion Criteria:

  • patients with previous treatments
  • patients with ocular surgeries

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
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Bevacizumab before panretinal photocoagulation.
Drug: bevacizumab
Intravitreal bevacizumab before panretinal photocoagulation
Drug: bevacizumab
Intravitreal Bevacizumab after panretinal photocoagulation
Experimental: Group B
Bevacizumab after panretinal photocoagulation
Drug: bevacizumab
Intravitreal bevacizumab before panretinal photocoagulation
Drug: bevacizumab
Intravitreal Bevacizumab after panretinal photocoagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Central macular thickness
Time Frame: baseline, 10 days, 52 days, 85 days
baseline, 10 days, 52 days, 85 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Best corrected visual acuity
Time Frame: baseline, 10 days, 52 days, 85 days
baseline, 10 days, 52 days, 85 days

Collaborators and Investigators

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

Sponsor

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)

July 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (Estimated)

December 8, 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-040

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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