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

January 3, 2008
February 21, 2014
February 2008
December 2010   (final data collection date for primary outcome measure)
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.

Mean change in VA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00593450 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Number of treatments [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • 3-line change in VA (15 letters on ETDRS chart) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in subretinal and intraretinal fluid on optical coherent tomography [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in lesion size on fluorescein angiography [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Incidence of endophthalmitis, retinal detachment, cataract, uveitis [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Cost [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Age Related Macular Degeneration
  • Drug: ranibizumab
    • 0.5 mg (0.05 mL)intravitreal injection
    Other Name: Lucentis
  • Drug: bevacizumab
    • 1.25 mg (0.05 mL)intravitreal injection
    Other Name: Avastin
  • 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.
    Intervention: Drug: ranibizumab
  • 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.
    Intervention: Drug: bevacizumab
  • 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.
    Intervention: Drug: ranibizumab
  • 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.
    Intervention: Drug: bevacizumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1208
November 2014
December 2010   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00593450
NEI-137, U10EY017823
Yes
Maureen Maguire, University of Pennsylvania
University of Pennsylvania
National Eye Institute (NEI)
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
University of Pennsylvania
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP