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POSTERIOR SUB-TENON'S Avastin

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ClinicalTrials.gov Identifier: NCT00567372
Recruitment Status : Unknown
Verified December 2008 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
First Posted : December 4, 2007
Last Update Posted : December 8, 2008
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México

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

Condition or disease Intervention/treatment Phase
Diffuse Diabetic Macular Edema Drug: bevacizumab (Sub-tenon´s injection) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: POSTERIOR SUB-TENON'S CAPSULE INJECTION OF BEVACIZUMAB FOR TREATMENT OF DIFFUSE DIABETIC MACULAR EDEMA
Study Start Date : June 2008
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab
U.S. FDA Resources


Intervention Details:
    Drug: bevacizumab (Sub-tenon´s injection)
    a single posterior sub-tenon's capsule injection of bevacizumab (2.5 mg /0.1ml)


Primary Outcome Measures :
  1. macular volume [ Time Frame: baseline, 3,6 and 12 weeks ]

Secondary Outcome Measures :
  1. macular thickness [ Time Frame: baseline,3,6 and 12 weeks ]
  2. best corrected visual acuity [ Time Frame: baseline, 3,6 and 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567372


Contacts
Contact: Sandra Vera-Rodriguez, MD 525510841400 ext 1171 retinamex@yahoo.com

Locations
Mexico
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

Responsible Party: Sandra Vera-Rodriguez, Asociación para Evitar la Ceguera en Mexico IAP
ClinicalTrials.gov Identifier: NCT00567372     History of Changes
Other Study ID Numbers: 00922
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: December 8, 2008
Last Verified: December 2008

Keywords provided by Asociación para Evitar la Ceguera en México:
Diffuse diabetic macular edema
sub-tenon
Bevacizumab

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents