Skip to main content
OpenTrials
Completed

NCT Number: NCT00593450

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Retina Consultants of Arizona, Mesa, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug
  • 0.5 mg (0.05 mL)intravitreal injection

Other names: Lucentis

Bevacizumab

Drug
  • 1.25 mg (0.05 mL)intravitreal injection

Other names: Avastin

Primary outcomes

  1. 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

  1. Change From Baseline Visual-acuity Score (Frequency)

    Time frame: Baseline and 1 Year

  2. Visual-acuity Score and Snellen Equivalent (Frequency)

    Time frame: at 1 Year

  3. Visual-acuity Score and Snellen Equivalent (Continuous)

    Time frame: at 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.

    In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity.

  4. Number of Treatments

    Time frame: 1 Year

    Cumulative over the 1 year of trial

  5. Average Cost of Drug/Patient

    Time frame: at 1 Year

  6. Total Thickness at Fovea

    Time frame: at 1 Year

  7. Total Thickness Change From Baseline at Fovea

    Time frame: Baseline and 1 Year

  8. Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea

    Time frame: at 1 Year

  9. Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea

    Time frame: Baseline and 1 Year

  10. Fluid on Optical Coherence Tomography

    Time frame: at 1 Year

  11. Dye Leakage on Angiogram

    Time frame: at 1 Year

  12. Area of Lesion

    Time frame: at 1 Year

  13. Area of Lesion Change From Baseline

    Time frame: Baseline and 1 Year

  14. Change in Systolic Blood Pressure From Baseline

    Time frame: Baseline and 1 Year

  15. Change in Diastolic Blood Pressure From Baseline

    Time frame: Baseline and 1 Year

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2015
First posted
Jan 15, 2008
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.