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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by Asociación para Evitar la Ceguera en México. Recruitment status was Recruiting

First Received on June 30, 2006. Last Updated on 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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

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

U.S. FDA Resources

Further study details as provided by Asociación para Evitar la Ceguera en México:

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
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

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

Keywords provided by Asociación para Evitar la Ceguera en México:

Macula
Edema

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses

Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012