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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2007

Last Updated Date

December 5, 2008

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Best corrected visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00567372 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

POSTERIOR SUB-TENON'S Avastin

Official Title ^ICMJE

POSTERIOR SUB-TENON'S CAPSULE INJECTION OF BEVACIZUMAB FOR TREATMENT OF DIFFUSE DIABETIC MACULAR EDEMA

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diffuse Diabetic Macular Edema

Intervention ^ICMJE

Drug: bevacizumab (Sub-tenon´s injection)

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

25 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sandra Vera-Rodriguez, MD

525510841400 ext 1171

retinamex@yahoo.com

Location Countries ^ICMJE

Mexico

Administrative Information

NCT Number ^ICMJE

NCT00567372

Other Study ID Numbers ^ICMJE

00922

Has Data Monitoring Committee

Responsible Party

Sandra Vera-Rodriguez, Asociación para Evitar la Ceguera en Mexico IAP

Study Sponsor ^ICMJE

Asociación para Evitar la Ceguera en México

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Asociación para Evitar la Ceguera en México

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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