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Efficacy of Retreatments With Intravitreal Bevacizumab

Primary Purpose

Age Related Macular Degeneration, Choroidal Neovascularization

Status

Unknown status

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Intravitreal injection of Bevacizumab

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring neovascularization

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

* Any visual acuity
- OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid.
- Active angiogram leakage

Exclusion Criteria:

* Basal Inflammatory disease
- Endoftalmitis history
- Lesions bigger than 5400 u or with scarring greater than 50% of lesion.

Sites / Locations

Asociacion para Evitar la Ceguera en MexicoRecruiting

Outcomes

Primary Outcome Measures

Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram

Secondary Outcome Measures

Full Information

NCT ID

NCT00406744

First Posted

November 30, 2006

Last Updated

November 30, 2006

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00406744

Brief Title

Efficacy of Retreatments With Intravitreal Bevacizumab

Official Title

Evaluation of Efficacy of Intravitreal Bevacizumab Retreatments

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Unknown status

Study Start Date

May 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

5. Study Description

Brief Summary

Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age Related Macular Degeneration, Choroidal Neovascularization

Keywords

neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Intravitreal injection of Bevacizumab

Primary Outcome Measure Information:

Title

Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: * Any visual acuity OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid. Active angiogram leakage Exclusion Criteria: * Basal Inflammatory disease Endoftalmitis history Lesions bigger than 5400 u or with scarring greater than 50% of lesion.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Veronica A Kon-Jara, MD

Phone

525510841400

Ext

1172

veronicakon@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hugo Quiroz-Mercado, MD

Phone

525510841400

Ext

1171

retinamex@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veronica Kon-Jara, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asociacion para Evitar la Ceguera en Mexico

City

Mexico DF

State/Province

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veronica Kon-Jara, MD

Phone

525510841400

Ext

1171

veronicakon@yahoo.com

First Name & Middle Initial & Last Name & Degree

Veronica Kon-Jara, MD

First Name & Middle Initial & Last Name & Degree

Mitzy Torres-Soriano, MD

First Name & Middle Initial & Last Name & Degree

Jose Luis Diaz-Rubio, MD

First Name & Middle Initial & Last Name & Degree

Myriam Hernandez, MD

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Retreatments With Intravitreal Bevacizumab

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