NCT00347399

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2007

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

June 30, 2006

Last Update Submit

May 29, 2024

Conditions

Age Related Macular Degeneration

Keywords

macular degenerationantibodiesangiogenesis inhibitor

Outcome Measures

Primary Outcomes (1)

  • Visual acuity improvement at 6 months

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Secondary Outcomes (1)

  • Retinal thickness improvement at 6 months

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Interventions

bevacizumab intravitreal injectionDRUG
verteporfin photodynamic therapyPROCEDURE

Eligibility Criteria

Age55 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old neovascular Age related acular degeneration subfoveolar neovascular membrane best corrected visual acuity better than 20/200 snellen (1.0 logMAR)

You may not qualify if:

  • Previously treated eyes glaucoma diabetes mellitus uncontrolled hypertension coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Luis Sanchez Bulnes

Mexico City, Mexico City, 04030, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 16156152BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hugo Quiroz-Mercado, MD

    Asociación para Evitar la Ceguera en México

    STUDY DIRECTOR

  • Jose Dalma Weizhaus, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

March 1, 2006

Primary Completion

June 30, 2006

Study Completion

June 30, 2007

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(1)