Avastin for Post-photocoagulation Macular Edema

NCT00801866 | Withdrawn Phase 4 DMC

• 1 other identifier: APEC-035
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Macular Edema

Keywords

Panretinal Photocoagulation; Macular Edema; Intravitreal Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

Secondary Outcomes (1)

• Central Retinal Thickness.

Study Arms (2)

Group 1

EXPERIMENTAL

Panretinal Photocoagulation + Bevacizumab

Drug: Bevacizumab

Group 2

EXPERIMENTAL

Panretinal Photocoagulation

Procedure: Panretinal Photocoagulation

Interventions

Bevacizumab DRUG

Intravitreal administration

Group 1

Panretinal Photocoagulation PROCEDURE

Panretinal Photocoagulation

Group 2

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Asociación para Evitar la Ceguera en México

Mexico City, Mexico City, 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 Officials

• Eduarto Torres-Porras, MD

  Asociación para Evitar la Ceguera en México

  STUDY DIRECTOR

• Octavio Burgos, MD

  Asociación para Evitar la Ceguera en México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 4, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

ME (1)