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Intravitreal Bevacizumab for Inflammatory Neovascular Membranes

Primary Purpose

Vogt Koyanagi Harada Disease, Serpiginous Choroiditis, Multifocal Choroiditis

Status

Completed

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Bevacizumab

Intravitreal Injection of Bevacizumab

About this trial

This is an interventional treatment trial for Vogt Koyanagi Harada Disease focused on measuring Neovascular Membrane, Uveitis, Bevacizumab

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical Diagnose
Patient Consent
Chronic stage of inflammation

Exclusion Criteria:

only eye
age lower than 30 yo.
Systemic condition

Sites / Locations

Asociacion para Evitar la Ceguera en Mexico

Outcomes

Primary Outcome Measures

Best corrected visual acuity

Retinal thickness by OCT

Leakage in Fluorescein angiogram

Secondary Outcome Measures

Full Information

NCT ID

NCT00407121

First Posted

December 1, 2006

Last Updated

December 1, 2006

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00407121

Brief Title

Intravitreal Bevacizumab for Inflammatory Neovascular Membranes

Official Title

Intravitreal Bevacizumab for the Treatment of Neovascular Membranes in Patients With Intraocular Inflammation

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Completed

Study Start Date

August 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

Intravitreal injection of Bevacizumab in patients with Neovascular Membranes secondary to intraocular inflammation. We injected a single injection of Bevacizumab (2.5 mg/0.1 ml) and evaluate visual acuity , Fluorescein angiogram and retinal thickness by Optical Coherence Tomography (OCT) in 4 patients with Vogt Koyanagi Harada disease, 1 patient with Serpiginous Choroidopathy and 1 patient with Multifocal Choroiditis.

6. Conditions and Keywords

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

Vogt Koyanagi Harada Disease, Serpiginous Choroiditis, Multifocal Choroiditis

Keywords

Neovascular Membrane, Uveitis, Bevacizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Type

Procedure

Intervention Name(s)

Intravitreal Injection of Bevacizumab

Primary Outcome Measure Information:

Title

Best corrected visual acuity

Title

Retinal thickness by OCT

Title

Leakage in Fluorescein angiogram

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical Diagnose Patient Consent Chronic stage of inflammation Exclusion Criteria: only eye age lower than 30 yo. Systemic condition

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

First Name & Middle Initial & Last Name & Degree

LuzElena Concha-Del Rio, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

Facility Information:

Facility Name

Asociacion para Evitar la Ceguera en Mexico

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

04030

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

Intravitreal Bevacizumab for Inflammatory Neovascular Membranes

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