POSTERIOR SUB-TENON'S Avastin

This study is currently recruiting participants.

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

Sponsored by:	Asociación para Evitar la Ceguera en México
Information provided by:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00567372

Purpose

Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema

Condition	Intervention	Phase
Diffuse Diabetic Macular Edema	Drug: bevacizumab (Sub-tenon´s injection)	Phase IV

MedlinePlus related topics: Edema

Drug Information available for: Bevacizumab

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title:	POSTERIOR SUB-TENON'S CAPSULE INJECTION OF BEVACIZUMAB FOR TREATMENT OF DIFFUSE DIABETIC MACULAR EDEMA

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

Primary Outcome Measures:

macular volume [ Time Frame: baseline, 3,6 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

macular thickness [ Time Frame: baseline,3,6 and 12 weeks ] [ Designated as safety issue: No ]
best corrected visual acuity [ Time Frame: baseline, 3,6 and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	7
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

a single posterior sub-tenon's capsule injection of bevacizumab (2.5 mg /0.1ml)

Eligibility

Criteria

Inclusion Criteria:

Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567372

Contacts

Contact: Sandra Vera-Rodriguez, MD

525510841400 ext 1171

Locations

Mexico, DF
Asociación para Evitar la Ceguera en Mexico	Recruiting
Mexico DF, DF, Mexico, 04030
Contact: Yoko Burgoa, Lic 525514841400 ext 1171 retinamex@yahoo.com

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México

Investigators

Principal Investigator:	Sandra Vera, MD	Asociación para Evitar la Ceguera en Mexico
Principal Investigator:	Hugo Quiroz-Mercado, MD	Denver Health Medical Center
Principal Investigator:	Adai Pérez-Montesinos, MD	Asociación para Evitar la Ceguera en Mexico

More Information

Responsible Party:	Asociación para Evitar la Ceguera en Mexico IAP ( Sandra Vera-Rodriguez )
Study ID Numbers:	00922
Study First Received:	November 30, 2007
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00567372
Health Authority:	Mexico: Ministry of Health

Keywords provided by Asociación para Evitar la Ceguera en México:

Diffuse diabetic macular edema
sub-tenon
Bevacizumab

Study placed in the following topic categories:

Signs and Symptoms
Macular Edema
Eye Diseases
Retinal Degeneration
Macular Degeneration

Edema
Bevacizumab
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009