A prospective, randomized, masked and controlled trial of intravitreal bevacizumab (Avastin) versus verteporfin photodynamic therapy (PDT) in patients with neovascular age-related macular degeneration.

• Conditions: Age-related macular degeneration (AMD) is the leading cause of visual impairment and social blindness in people 60 years or older. Approximately 75% of patients with severe visual loss exhibit neovascular AMD with choroidal neovascularization (CNV). Newly formed vessels invade the retinal pigment epithelium (RPE) and neural retina, causing edema and hemorrhage, ultimately inducing damage or apoptotic cell death of photoreceptors.

• Registration Number: EUCTR2006-001200-36-SE
• Lead Sponsor: St. Eriks Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with neovascular AMD aged 50 years or more who have a visual acuity
0,1 (20/200) or better
- Classic or predominantly classic choroidal neovascularization (CNV)
- Occult CNV with extension 4 disc areas or less

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients < 50 years of age
- Minimally classic CNV (predominantly occult CNV)
- Occult CNV with lesions > 4 disc areas
- Subretinal hemorrhage involving macular area and which is >= 1 disc area
or >=50% of the total lesion
- Subretinal fibrosis in the fovea
- Previous treatment using vitreoretinal surgery, PDT, transpupillary thermotherapy (TTT), argon or krypton laser, anecortave acetate or anti-VEGF agents for ocular use.
- Retinal vascular disease of any origin, leading to neovascularization
- Diabetic retinopathy
- Uncontrolled arterial hypertension
- Coronary infarction within the last 12 months
- Stroke within the last 12 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the safety and efficacy of intravitreal bevacizumab (Avastin) with verteporfin photodynamic therapy (PDT) in patients with neovascular AMD. <br><br>This Avastin vs. PDT for neovascular AMD Study will evaluate whether treatment with intravitreal bevacizumab yields better visual and clinical results than conventional verteporfin PDT. ;Secondary Objective: Fraction (per centage) of patients who maintain visual acuity (losing < 15 ETDRS letters) from baseline<br>Fraction (per centage) of patients who gain at least 15 ETDRS letters from baseline;Primary end point(s): - Fraction (number) of patients who lose < 15 ETDRS letters from baseline<br>- Fraction (number) of patients who gain at least 15 ETDRS letter from baseline