Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

NCT00600301 | Withdrawn Phase 3

• 1 other identifier: APEC-OO13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.

Conditions

Diffuse Diabetic Macular Edema

Keywords

Macula; Edema

Interventions

Triamcinolone Acetonide and Bevacizumab DRUG

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diffuse diabetic macular edema
• Non proliferative diabetic retinopathy
• No VPP previa
• No previous treament with laser, Triamcinolone acetonide, and Bevacizumab

You may not qualify if:

• Proliferative diabetic retinopathy
• Previous pars plana vitrectomy
• Previous treatment with diabetic macular edema
• Focal macular edema
• Macular Ischemia

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Asociacion Para Evitar la Ceguera en Mexico

México, 04030, Mexico

Location

MeSH Terms

Conditions

Edema

Interventions

Triamcinolone Acetonide; Bevacizumab

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Maximiliano Gordon, MD

  Asociación para Evitar la Ceguera en México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: January 24, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

ME (1)