List of Participating Centers

Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)

The purpose of the study is to evaluate the relative efficacy and safety of treatment of subfoveal, neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

Age-related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. More than 1.6 million people in the US currently have one or both eyes affected by the advanced stage of AMD.

Lucentis® is the most effective treatment for neovascular AMD studied to date and has become the standard of care. Bevacizumab (Avastin®) and Lucentis® are derived from the same monoclonal antibody. Following the encouraging clinical trial results with Lucentis®, several investigators began evaluating intravitreal Avastin® for the treatment of choroidal neovascularization (CNV). Given its molecular similarity to Lucentis, its low cost, and its availability, the interest in Avastin® has been considerable. Avastin® has not been evaluated relative to Lucentis®.

In addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. Treatment dependent on clinical response has the potential to reduce the treatment burden to patients as well as to reduce the overall cost of therapy.

The Lucentis-Avastin Trial is a multi-center, randomized, clinical trial designed to identify the best approach to anti-VEGF therapy to be used as the standard of comparison for subsequent clinical trials for neovascular age-related macular degeneration. Only one eye of each person may be enrolled.

The trial will involve 4 treatment groups:

1. Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
2. Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
3. Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
4. Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.

The effectiveness of the treatments will be assessed using the following criteria:

• Change in visual acuity (VA) at one year (primary outcome measure of the study)
• Number of treatments
• 3-line change in VA
• Change in subretinal and intraretinal fluid on optical coherence tomography
• Change in lesion size on fluorescein angiography
• Incidence of endophthalmitis, retinal detachment, cataract, uveitis
• Incidence of adverse events
• Cost

Eligibility criteria are designed to be as inclusive as possible. The vast majority of patients with new, subfoveal CNV are eligible for the Lucentis-Avastin Trial.

• Active, subfoveal CNV
• Fibrosis < 50 percent of total lesion area
• Visual acuity 20/25-20/320
• Age 50 yrs or older
• 1 drusen or more (>63µ) in either eye or late AMD in fellow eye
• No previous treatment for CNV in study eye
• No other progressive retinal disease likely to compromise visual acuity
• No contraindications to injections with Lucentis® or Avastin®

Recruiting. Comments: Recruitment began in February 2008.

Ongoing. Comments:

Results not yet available.