NCT00390026

Brief Summary

The object of the study is to compare the treatment effect of bevacizumab (Avastin), an antibody targeting vascular endothelial growth factor, with verteporfin photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration, the leading cause of vision severe loss in the Western world.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

October 17, 2006

Last Update Submit

January 28, 2024

Conditions

Age-related Macular Degeneration

Keywords

Neovascular age-related macular degenerationBevacizumabPhotodynamic therapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.

    1 year

Secondary Outcomes (2)

  • Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart.

    1 year

  • Proportion of patients losing more than 30 letters on the ETDRS visual acuity chart.

    1 year

Study Arms (2)

Avastin

EXPERIMENTAL
Drug: Bevacizumab (Avastin)Drug: Verteporfin photodynamic therapy (PDT)

Visudyne

ACTIVE COMPARATOR
Drug: Bevacizumab (Avastin)Drug: Verteporfin photodynamic therapy (PDT)

Interventions

Bevacizumab (Avastin)DRUG
AvastinVisudyne
Verteporfin photodynamic therapy (PDT)DRUG
AvastinVisudyne

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with subfoveal neovascular AMD with either classic/predominantly classic or small occult lesions
  • visual acuity \>=0.1

You may not qualify if:

  • patients with subfoveal neovascular AMD with minimally classic lesions or large occult lesions
  • subfoveal hemorrhage (\>1DA) or fibrosis
  • patients previously treated for neovascular AMD in the study eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S:t Eriks Eye Hospital

Stockholm, SE-11282, Sweden

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Anders Kvanta, MD, PhD

    S:t Erik's Eye Hospital

    PRINCIPAL INVESTIGATOR

  • Stefan Seregard, MD, PhD

    S:t Eriks Eye Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 19, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

SE(1)