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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Age Related Macular Degeneration

Intervention / Treatment
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* Drug: ranibizumab
* Drug: bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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. | Drug: ranibizumab<br>* • 0.5 mg (0.05 mL)intravitreal injection<br>* Other names: Lucentis;|
| Experimental: 2<br>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. | Drug: bevacizumab<br>* • 1.25 mg (0.05 mL)intravitreal injection<br>* Other names: Avastin;|
| Experimental: 3<br>Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. | Drug: ranibizumab<br>* • 0.5 mg (0.05 mL)intravitreal injection<br>* Other names: Lucentis;|
| Experimental: 4<br>Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. | Drug: bevacizumab<br>* • 1.25 mg (0.05 mL)intravitreal injection<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Visual-acuity Score (Continuous) | 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. | Baseline and 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Visual-acuity Score (Frequency) |  | Baseline and 1 Year | 
| Visual-acuity Score and Snellen Equivalent (Frequency) |  | at 1 Year | 
| Visual-acuity Score and Snellen Equivalent (Continuous) | 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. In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity. | at 1 Year | 
| Number of Treatments | Cumulative over the 1 year of trial | 1 Year | 
| Average Cost of Drug/Patient |  | at 1 Year | 
| Total Thickness at Fovea |  | at 1 Year | 
| Total Thickness Change From Baseline at Fovea |  | Baseline and 1 Year | 
| Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea |  | at 1 Year | 
| Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea |  | Baseline and 1 Year | 
| Fluid on Optical Coherence Tomography |  | at 1 Year | 
| Dye Leakage on Angiogram |  | at 1 Year | 
| Area of Lesion |  | at 1 Year | 
| Area of Lesion Change From Baseline |  | Baseline and 1 Year | 
| Change in Systolic Blood Pressure From Baseline |  | Baseline and 1 Year | 
| Change in Diastolic Blood Pressure From Baseline |  | Baseline and 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bevacizumab, ranibizumab, choroidal neovascularization