NCT00805064

Brief Summary

The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Status
completed

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

January 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

1.9 years

First QC Date

December 4, 2008

Last Update Submit

September 26, 2012

Conditions

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • BCVA

    day of exam

Study Arms (3)

ischemic CRVO

ACTIVE COMPARATOR

treatment was applied to this entity

Drug: triamcinolone and bevacizumab

non ischemic CRVO

ACTIVE COMPARATOR

treatment was applied to this entity

Drug: triamcinolone and bevacizumab

BRVO

ACTIVE COMPARATOR

treatment was applied to this entity

Drug: triamcinolone and bevacizumab

Interventions

triamcinolone and bevacizumabDRUG
BRVOischemic CRVOnon ischemic CRVO

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic central RVO (CRVO)
  • Non-ischemic CRVO
  • Branch RVO (BRVO)

You may not qualify if:

  • Visual deterioration due to acute or chronic inflammation
  • Post trauma
  • Macular edema of other origin
  • Intravitreal drug treatment within last 4 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

TriamcinoloneBevacizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Michael Koss, MD

    Department of VitreoRetinal Surgery ZAU JWGU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 9, 2008

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

November 1, 2008

Last Updated

September 27, 2012

Record last verified: 2012-09