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Effect of Avastin in Juxtafoveal Telangiectasias

Primary Purpose

Telangiectasis

Status

Unknown status

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Bevacizumab

Intravitreal injection of Bevacizumab

About this trial

This is an interventional treatment trial for Telangiectasis focused on measuring Telangiectasias, Leakage, Bevacizumab, Telangiectasias secondary to Branch Retinal Vein Occlusion (BRVO), Idiopathic juxtafoveal retinal telangiectasias

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

Patients with Telangiectasias secondary to Branch Retinal Vein Occlusion
Patients with Idiopathic Juxtafoveal Retinal Telangiectasias

Exclusion Criteria:

Diabetic Retinopathy and Diabetic Macular Edema
Hypertensive Retinopathy
Choroidal Neovascularization

Sites / Locations

Asociacion para Evitar la Ceguera en MexicoRecruiting

Outcomes

Primary Outcome Measures

Best corrected Visual Acuity

Fluorescein Angiogram: Leakage

Optical Coherence Tomography: Retinal thickness

Secondary Outcome Measures

Full Information

NCT ID

NCT00406380

First Posted

November 30, 2006

Last Updated

December 1, 2006

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00406380

Brief Title

Effect of Avastin in Juxtafoveal Telangiectasias

Official Title

Does Avastin Change Evolution in Juxtafoveal Telangiectasias?

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Unknown status

Study Start Date

September 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

Evaluation of efficacy of Intravitreal Injection of Bevacizumab in patients with Yuxtafoveal Telangiectasias

Detailed Description

After diagnose Yuxtafoveal telangiectasias secondary to Branch Retinal Vein Occlusion and with Idiopathic Ethiology by clinical signs and Fluorescein angiogram (FA)findings we treated patients with Intravitreal Injection of Bevacizumab (2.5mg/0.1ml). We performed a complete ophthalmological evaluation and at baseline and follow-up (1 and 3 months) we evaluate ETDRS Best Corrected visual acuity (BCVA), fluorescein angiogram (FA) and Optical Coherence Tomography (OCT)findings. We found an improvement in visual acuity and reduction of FA leakage and decrease retinal thickness in OCT.

6. Conditions and Keywords

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

Telangiectasis

Keywords

Telangiectasias, Leakage, Bevacizumab, Telangiectasias secondary to Branch Retinal Vein Occlusion (BRVO), Idiopathic juxtafoveal retinal telangiectasias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial 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

Fluorescein Angiogram: Leakage

Title

Optical Coherence Tomography: Retinal thickness

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Eligibility Criteria

Inclusion Criteria: Patients with Telangiectasias secondary to Branch Retinal Vein Occlusion Patients with Idiopathic Juxtafoveal Retinal Telangiectasias Exclusion Criteria: Diabetic Retinopathy and Diabetic Macular Edema Hypertensive Retinopathy Choroidal Neovascularization

Central Contact Person:

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

Verónica Kon-Jara, MD

Phone

5510841400

Ext

1171-1172

veronicakon@yahoo.com

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

Orlando Ustariz-Gonzalez, MD

Phone

5510841400

Ext

1171-1172

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

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

5510841400

Ext

1171-1172

veronicakon@yahoo.com

First Name & Middle Initial & Last Name & Degree

Orlando Ustariz-Gonzalez, MD

First Name & Middle Initial & Last Name & Degree

Elizabeth Reyna-Castelan, MD

First Name & Middle Initial & Last Name & Degree

Nelida Salazar-Teran, MD

First Name & Middle Initial & Last Name & Degree

Jans Fromow-Guerra, MD

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, MD

12. IPD Sharing Statement

Learn more about this trial

Effect of Avastin in Juxtafoveal Telangiectasias

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