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Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

Primary Purpose

Age Related Macular Degeneration

Status

Unknown status

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

bevacizumab intravitreal injection

verteporfin photodynamic therapy

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring macular degeneration, antibodies, angiogenesis inhibitor

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 55 years old neovascular Age related acular degeneration subfoveolar neovascular membrane best corrected visual acuity better than 20/200 snellen (1.0 logMAR) Exclusion Criteria: Previously treated eyes glaucoma diabetes mellitus uncontrolled hypertension coronary artery disease

Sites / Locations

Hospital Luis Sanchez BulnesRecruiting

Outcomes

Primary Outcome Measures

Visual acuity improvement at 6 months

Secondary Outcome Measures

Retinal thickness improvement at 6 months

Full Information

NCT ID

NCT00347399

First Posted

June 30, 2006

Last Updated

June 30, 2006

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00347399

Brief Title

Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

Official Title

Effects of Intravitreal Injection of Bevacizumab in Combination With Verteporfin Photodynamic Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2006

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine if of combination therapy of intravitreal bevacizumab 4 days after the application of photodynamic therapy could improve the visual outcomes of patients with neovascular age related macular degeneration.

Detailed Description

The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined. The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD 4 days after photodynamic therapy with verteporfin

6. Conditions and Keywords

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

Age Related Macular Degeneration

Keywords

macular degeneration, antibodies, angiogenesis inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

bevacizumab intravitreal injection

Intervention Type

Procedure

Intervention Name(s)

verteporfin photodynamic therapy

Primary Outcome Measure Information:

Title

Visual acuity improvement at 6 months

Secondary Outcome Measure Information:

Title

Retinal thickness improvement at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

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

Dalma Jose Dalma-Weizhaus

Phone

10841400

Ext

1171

draojitos26@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jose Dalma Weizhaus, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Luis Sanchez Bulnes

City

Mexico city

State/Province

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, MD

Phone

525510841400

retinamex@yahoo.com

First Name & Middle Initial & Last Name & Degree

Maura L Abraham Marin, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

16156152

Citation

Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5.

Results Reference

background

Learn more about this trial

Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

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