Overview

This trial is active, not recruiting.

Condition age related macular degeneration
Treatments ranibizumab, bevacizumab
Phase phase 3
Target VEGF
Sponsor University of Pennsylvania
Collaborator National Eye Institute (NEI)
Start date February 2008
End date December 2010
Trial size 1208 participants
Trial identifier NCT00593450, NEI-137, U10EY017823

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
ranibizumab Lucentis
• 0.5 mg (0.05 mL)intravitreal injection
(Experimental)
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.
bevacizumab Avastin
• 1.25 mg (0.05 mL)intravitreal injection
(Experimental)
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
ranibizumab Lucentis
• 0.5 mg (0.05 mL)intravitreal injection
(Experimental)
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
bevacizumab Avastin
• 1.25 mg (0.05 mL)intravitreal injection

Primary Outcomes

Measure
Change From Baseline in Visual-acuity Score (Continuous)
time frame: Baseline and 1 Year

Secondary Outcomes

Measure
Change From Baseline Visual-acuity Score (Frequency)
time frame: Baseline and 1 Year
Visual-acuity Score and Snellen Equivalent (Frequency)
time frame: at 1 Year
Visual-acuity Score and Snellen Equivalent (Continuous)
time frame: at 1 Year
Number of Treatments
time frame: 1 Year
Average Cost of Drug/Patient
time frame: at 1 Year
Total Thickness at Fovea
time frame: at 1 Year
Total Thickness Change From Baseline at Fovea
time frame: Baseline and 1 Year
Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea
time frame: at 1 Year
Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea
time frame: Baseline and 1 Year
Fluid on Optical Coherence Tomography
time frame: at 1 Year
Dye Leakage on Angiogram
time frame: at 1 Year
Area of Lesion
time frame: at 1 Year
Area of Lesion Change From Baseline
time frame: Baseline and 1 Year
Change in Systolic Blood Pressure From Baseline
time frame: Baseline and 1 Year
Change in Diastolic Blood Pressure From Baseline
time frame: Baseline and 1 Year

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Principal investigator Juan E Grunwald, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of Pennsylvania.