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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Maureen Maguire, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00593450
First received: January 3, 2008
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: ranibizumab
Drug: bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change From Baseline in Visual-acuity Score (Continuous) [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Change From Baseline Visual-acuity Score (Frequency) [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Visual-acuity Score and Snellen Equivalent (Frequency) [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Visual-acuity Score and Snellen Equivalent (Continuous) [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]

    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.


  • Number of Treatments [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Cumulative over the 1 year of trial

  • Average Cost of Drug/Patient [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Total Thickness at Fovea [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Total Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Fluid on Optical Coherence Tomography [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Dye Leakage on Angiogram [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Area of Lesion [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Area of Lesion Change From Baseline [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]

Enrollment: 1208
Study Start Date: February 2008
Estimated Study Completion Date: November 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: ranibizumab
• 0.5 mg (0.05 mL)intravitreal injection
Other Name: Lucentis
Experimental: 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.
Drug: bevacizumab
• 1.25 mg (0.05 mL)intravitreal injection
Other Name: Avastin
Experimental: 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.
Drug: ranibizumab
• 0.5 mg (0.05 mL)intravitreal injection
Other Name: Lucentis
Experimental: 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.
Drug: bevacizumab
• 1.25 mg (0.05 mL)intravitreal injection
Other Name: Avastin

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593450

  Show 59 Study Locations
Sponsors and Collaborators
University of Pennsylvania
Investigators
Study Chair: Daniel F Martin, MD The Cleveland Clinic
Study Chair: Stuart L Fine, MD Study Vice-Chair, University of Pennsylvania
Study Director: Maureen G Maguire, PhD Director of Coordinating Center, University of Pennsylvania
Study Director: Glenn Jaffe,, MD Director of OCT Reading Center, Duke University
Principal Investigator: Juan E Grunwald, MD Principal Investigator of Photography Reading Center, Universisty of Pennsylvania
  More Information

Additional Information:
Publications:
Martin DF, Maguire MG, Fine SL. Ranibizumab and bevacizumab for AMD. Authors reply. N Engl J Med 2011; 365:2237

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maureen Maguire, Carolyn F. Jones Professor of Ophthalmology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00593450     History of Changes
Other Study ID Numbers: NEI-137, U10EY017823
Study First Received: January 3, 2008
Results First Received: June 18, 2012
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
bevacizumab
ranibizumab
choroidal neovascularization

Additional relevant MeSH terms:
Bevacizumab
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014