NCT01044329

Brief Summary

This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 7, 2010

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

January 6, 2010

Last Update Submit

January 6, 2010

Conditions

Branch Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    6 months

Secondary Outcomes (1)

  • central macular thickness

    6 months

Study Arms (2)

Intravitreal bevacizumab

ACTIVE COMPARATOR
Drug: Bevacizumab

Intravitreal triamcinolone

ACTIVE COMPARATOR
Drug: Triamcinolone Acetonide

Interventions

BevacizumabDRUG

Intravitreal, 1.25 mg, 3 times, one month apart.

Intravitreal bevacizumab
Triamcinolone AcetonideDRUG

Intravitreal, 2 mg, 2 times, two months apart.

Intravitreal triamcinolone

Eligibility Criteria

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

You may qualify if:

  • Recent onset (less than 3 months) BRVO

You may not qualify if:

  • Any previous intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Hossein medical center

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

BevacizumabTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

January 7, 2010

Record last verified: 2010-01

Locations

IR(1)