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

This study is currently recruiting participants.

Verified by Asociación para Evitar la Ceguera en México, January 2008

First Received: June 30, 2006 Last Updated: January 23, 2008 History of Changes

Sponsor:	Asociación para Evitar la Ceguera en México
Information provided by:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00600301

Purpose

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.

Condition	Intervention	Phase
Diffuse Diabetic Macular Edema	Drug: Triamcinolone Acetonide and Bevacizumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Bevacizumab Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	20 Years to 90 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600301

Contacts

Contact: Maximiliano Gordon, MD

10841400 ext 1171, 1172

retinamex@yahoo.com

Locations

Mexico, D.F.
Asociacion Para Evitar la Ceguera en Mexico	Recruiting
Mexico D.F., D.F., Mexico, 04030
Contact: Maximiliano Gordon, MD 10841400 ext 1171, 1172 retinamex@yahoo.com

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México

Investigators

Principal Investigator:

Maximiliano Gordon, MD

APEC

More Information

No publications provided

Study ID Numbers:	APEC-OO13
Study First Received:	June 30, 2006
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00600301 History of Changes
Health Authority:	Mexico: Secretaria de Salud

Keywords provided by Asociación para Evitar la Ceguera en México:

Macula
Edema

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Bevacizumab
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Therapeutic Uses

Triamcinolone
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases
Growth Substances
Eye Diseases
Retinal Degeneration
Macular Degeneration
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009