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

• Sponsor: Asociación para Evitar la Ceguera en México (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00804206
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema	Drug: bevacizumab; Drug: bevacizumab	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 4 Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation
• Study Start Date: Jul 1, 2008
• Anticipated Primary Completion Date: Jul 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Central macular thickness [baseline, 10 days, 52 days, 85 days]

Secondary Outcome Measures

1. Best corrected visual acuity [baseline, 10 days, 52 days, 85 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with proliferative diabetic retinopathy

• patients with macular edema

Exclusion Criteria:

• patients with previous treatments

• patients with ocular surgeries

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asociación para Evitar la Ceguera en México	México		Mexico	04030

Sponsors and Collaborators

• Asociación para Evitar la Ceguera en México

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00804206
• Other Study ID Numbers: APEC-040
• First Posted: Dec 8, 2008
• Last Update Posted: Dec 8, 2008
• Last Verified: Dec 1, 2008

• Keywords provided by , ,: Intravitreal injection of Bevacizumab; Visual acuity; central retinal thickness; color studies, Farnsworth-Munsell; electroretinogram studies
• Additional relevant MeSH terms: Macular Edema; Bevacizumab

Study Results

No Results Posted as of Dec 8, 2008