NCT00906685

Brief Summary

Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

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, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

1.8 years

First QC Date

May 20, 2009

Last Update Submit

November 21, 2011

Conditions

Central Retinal Vein Occlusion

Keywords

CRVOanti-VEGFMacular edema

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients gaining 15 ETDRS letters or more

    6 months

Secondary Outcomes (2)

  • Change in foveal thickness

    6 months

  • Cases of neovascular glaucoma

    6 months

Study Arms (2)

Intravitreal bevacizumab

ACTIVE COMPARATOR
Drug: bevacizumab

Sham injection

SHAM COMPARATOR
Drug: Sham bevacizumab injection

Interventions

bevacizumabDRUG

Intravitreal injection of 1.25 mg bevacizumab

Intravitreal bevacizumab
Sham bevacizumab injectionDRUG

Sham intravitreal injection

Sham injection

Eligibility Criteria

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

You may qualify if:

  • CRVO with duration \< 6 months
  • Visual acuity of 20/800 to 20/50

You may not qualify if:

  • CRVO with duration of \> 6 months
  • previous treatment with anti-angiogenic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Eriks Eye Hospital

Stockholm, 11282, Sweden

Location

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Anders Kvanta, MD, PhD

    St Eriks Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2011

Study Completion

September 1, 2011

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

SE(1)