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

NCT00804206 | Terminated Phase 4

• 1 other identifier: APEC-040
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Edema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Central macular thickness

  baseline, 10 days, 52 days, 85 days

Secondary Outcomes (1)

• Best corrected visual acuity

  baseline, 10 days, 52 days, 85 days

Study Arms (2)

Group A

EXPERIMENTAL

Bevacizumab before panretinal photocoagulation.

Drug: bevacizumab

Group B

EXPERIMENTAL

Bevacizumab after panretinal photocoagulation

Drug: bevacizumab

Interventions

bevacizumab DRUG

Intravitreal bevacizumab before panretinal photocoagulation

Group A

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with proliferative diabetic retinopathy
• patients with macular edema

You may not qualify if:

• patients with previous treatments
• patients with ocular surgeries

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Asociación para Evitar la Ceguera en México

México, 04030, Mexico

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 8, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

ME (1)