Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Overview
- Phase
- Phase 3
- Intervention
- ranibizumab
- Conditions
- Age Related Macular Degeneration
- Sponsor
- University of Pennsylvania
- Enrollment
- 1208
- Locations
- 51
- Primary Endpoint
- Change From Baseline in Visual-acuity Score (Continuous)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.
A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.
Detailed Description
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. 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 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. Only a single eye in each patient was analyzed. At the five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however, the five year follow-up visit deos not involve any study treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Active, subfoveal choroidal neovascularization (CNV)
- •Fibrosis \< 50% of total lesion area
- •Visual acuity (VA) 20/25-20/320
- •Age ≥ 50 yrs
- •At least 1 drusen (\>63μ) in either eye or late AMD in fellow eye
Exclusion Criteria
- •Previous treatment for CNV in study eye
- •Other progressive retinal disease likely to compromise VA
- •Contraindications to injections with Lucentis or Avastin
Arms & Interventions
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.
Intervention: ranibizumab
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.
Intervention: bevacizumab
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.
Intervention: ranibizumab
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.
Intervention: bevacizumab
Outcomes
Primary Outcomes
Change From Baseline in Visual-acuity Score (Continuous)
Time Frame: Baseline and 1 Year
Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline. In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement.
Secondary Outcomes
- Fluid on Optical Coherence Tomography(at 1 Year)
- Area of Lesion Change From Baseline(Baseline and 1 Year)
- Number of Treatments(1 Year)
- Dye Leakage on Angiogram(at 1 Year)
- Visual-acuity Score and Snellen Equivalent (Frequency)(at 1 Year)
- Visual-acuity Score and Snellen Equivalent (Continuous)(at 1 Year)
- Change in Diastolic Blood Pressure From Baseline(Baseline and 1 Year)
- Change From Baseline Visual-acuity Score (Frequency)(Baseline and 1 Year)
- Total Thickness Change From Baseline at Fovea(Baseline and 1 Year)
- Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea(Baseline and 1 Year)
- Average Cost of Drug/Patient(at 1 Year)
- Total Thickness at Fovea(at 1 Year)
- Area of Lesion(at 1 Year)
- Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea(at 1 Year)
- Change in Systolic Blood Pressure From Baseline(Baseline and 1 Year)