POSTERIOR SUB-TENON'S Avastin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00567372
First received: November 30, 2007
Last updated: December 5, 2008
Last verified: December 2008
  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 4

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

Resource links provided by NLM:


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

Ages Eligible for Study:   25 Years to 90 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: November 30, 2007
Last Updated: December 5, 2008
Health Authority: Mexico: Ministry of Health

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014