Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

This study is currently recruiting participants.

Verified by Asociación para Evitar la Ceguera en México, December 2007

First Received: December 7, 2007 No Changes Posted

Sponsor:	Asociación para Evitar la Ceguera en México
Information provided by:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00571142

Purpose

To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease.

Condition	Intervention	Phase
* Diffuse Diabetic Macular Edema	Procedure: Bevacizumab + Pars plana vitrectomy Procedure: Bevacizumab + pars plana vitrectomy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Bevacizumab Temazepam

U.S. FDA Resources

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

Primary Outcome Measures:

Retinal thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	February 2008

Arms	Assigned Interventions
1: Active Comparator Renal disease	Procedure: Bevacizumab + Pars plana vitrectomy 2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.
2: Active Comparator Without renal disease	Procedure: Bevacizumab + pars plana vitrectomy 2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Older than 25 yo
Diffuse diabetic macular edema with or without previous treatment

Exclusion Criteria:

Another retinal disease
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571142

Contacts

Contact: Veronica Kon-Jara, MD	5215537291895	veronicakon@yahoo.com
Contact: Antonieta Burgoa	10841400 ext 1171	retinamex@yahoo.com

Locations

Mexico
Asociacion para Evitar la Ceguera en Mexico I.A.P.	Recruiting
Mexico, Mexico, 04030
Sub-Investigator: Ma Ana Martinez-Castellanos, MD
Sub-Investigator: Oscar Alvarez-Verduzco, MD
Sub-Investigator: Jose Luis Guerrero-Naranjo, MD
Sub-Investigator: Hugo Quiroz-Mercado, MD

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México

Investigators

Principal Investigator:

Veronica Kon-Jara, MD

Asociacion para Evitar la Ceguera en Mexico

More Information

No publications provided

Responsible Party:	Asociacion para Evitar la Ceguera en Mexico I.A.P. ( Veronica Kon-Jara MD )
Study ID Numbers:	APEC-ret
Study First Received:	December 7, 2007
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00571142 History of Changes
Health Authority:	Mexico: Subsecretary of Ministry of Health, Mexico city

Keywords provided by Asociación para Evitar la Ceguera en México:

edema
retinal thickness
diabetic retinopathy

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Edema
Bevacizumab
Signs and Symptoms
Macular Edema
Therapeutic Uses
Hypnotics and Sedatives
Growth Inhibitors
Angiogenesis Modulating Agents

Retinal Diseases
Tranquilizing Agents
Eye Diseases
Growth Substances
Temazepam
Central Nervous System Depressants
Retinal Degeneration
Macular Degeneration
Angiogenesis Inhibitors
Pharmacologic Actions
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009