The Avastin vs Visudyne for Neovascular AMD Study

January 28, 2024 updated by: Anders Kvanta, St. Erik Eye Hospital

A Prospective, Randomized, Double-masked, Controlled Study on Intravitreal Bevacizumab (Avastin) Versus Verteporfin (Visudyne) Photodynamic Therapy (PDT) for Patients With Neovascular Age-related Macular Degeneration (AMD)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. Current treatment options have up until now been limited to photodynamic therapy (PDT) where a photosensitizing agent in combination with laser is used to occlude the pathologic vessels. Anti-VEGF agents have recently become available making them a potentially attractive treatment alternative for neovascular AMD. We will compare the effect intravitreally administered bevacizumab with conventional PDT in a prospective, randomized and controlled trial including 100 patients (50 patients receiving either treatment regimen). Non-treated patients will receive either sham-injection or sham-PDT. The primary endpoint of the study is the amount of patients losing less than 15 letters on the ETDRS visual acuity chart. The study will go on for 2 years with an interim report after 1 year.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-11282
        • S:t Eriks Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Avastin
Drug: Bevacizumab (Avastin)
Drug: Verteporfin photodynamic therapy (PDT)
Active Comparator: Visudyne
Drug: Bevacizumab (Avastin)
Drug: Verteporfin photodynamic therapy (PDT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart.
Time Frame: 1 year
1 year
Proportion of patients losing more than 30 letters on the ETDRS visual acuity chart.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Erik Eye Hospital

Investigators

  • Principal Investigator: Anders Kvanta, MD, PhD, S:t Erik's Eye Hospital
  • Study Director: Stefan Seregard, MD, PhD, S:t Eriks Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimated)

October 19, 2006

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVA001
  • EU2006-001200-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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