The Avastin vs Visudyne for Neovascular AMD Study

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)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00390026

Enrollment

Registered

2006-10-19

Start date

2006-11-30

Completion date

2008-11-30

Last updated

2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration

Keywords

Neovascular age-related macular degeneration, Bevacizumab, Photodynamic therapy

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.

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.

Interventions

DRUGBevacizumab (Avastin)

DRUGVerteporfin photodynamic therapy (PDT)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026