NCT00566761

Brief Summary

Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_4

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

June 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

November 30, 2007

Last Update Submit

May 29, 2024

Conditions

Macular EdemaCentral Retinal Vein Occlusion

Keywords

Macular edemacentral retinal vein occlusionbevacizumabtriamcinolone

Outcome Measures

Primary Outcomes (1)

  • Changes in Best corrected visual acuity and macular edema measured with OCT

    Follow up to 3 , 6 and 12 months

Secondary Outcomes (1)

  • Report treatment complications

    12 month

Interventions

bevacizumab and triamcinoloneDRUG

three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Macular edema secondary to central retinal vein occlusion
  • BCVA worse than 20/40
  • Central macular \>250 mc with OCT

You may not qualify if:

  • Diabetic retinopathy or other retinopathy
  • Media opacity that does not allow following
  • steroid responder
  • diagnosed glaucoma or IOP \> 21 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion Para Evitar la Ceguera en Mexico

Mexico City, Coyoacan, 04030, Mexico

Location

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Interventions

BevacizumabTriamcinolone

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Carmen Gonzalez-Mijares, Physician

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

  • Hugo Quiroz-Mercado, Retinologyst

    Asociación para Evitar la Ceguera en México

    STUDY DIRECTOR

  • Juan Manuel Jimenez Sierra, Retinologyst

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • MA Martinez-Castellanos, Physician

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • Octavio Burgos Vejar, Physician

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • Raul Velez-Montoya, Physician

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • Ma de Lourdes Lopez Ramos, Physician

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • Omar Honerlager, preresident

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2007

Study Completion

March 1, 2008

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(1)