NCT00406744

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2006

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

November 30, 2006

Last Update Submit

May 31, 2024

Conditions

Keywords

neovascularization

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram

Interventions

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion para Evitar la Ceguera en Mexico

Mexico City, Mexico City, 04030, Mexico

Location

MeSH Terms

Conditions

Macular DegenerationChoroidal NeovascularizationNeovascularization, Pathologic

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Veronica Kon-Jara, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2006

Study Completion

November 1, 2006

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations