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Age Related Macular DegenerationPhase 3NCT00593450

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

A Phase 3 study testing ranibizumab and bevacizumab in people with Age Related Macular Degeneration, run by University of Pennsylvania at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age Related Macular Degeneration
What is being tested?
ranibizumab and bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,208 participants
Where
59 sitesUnited States
Study dates
Feb 2008to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Previous treatment for CNV in study eye
  • Other progressive retinal disease likely to compromise VA
  • Contraindications to injections with Lucentis or Avastin

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Emory Eye Center

    Atlanta, Georgia, 30322

  • California Retina Consultants

    Bakersfield, California, 93309

  • Elman Retina Group, P.A.

    Baltimore, Maryland, 21237

  • Retina Associates of Cleveland

    Beachwood, Ohio, 44122

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Massachusetts Eye & Ear Infirmary

    Boston, Massachusetts, 02114

  • Opthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Harvard Vanguard Medical Associates

    Boston, Massachusetts, 02459

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Charlotte Eye, Ear, nose & Throat Associates

    Charlotte, North Carolina, 28210

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Colorado Retina Associates

    Denver, Colorado, 80457

  • Ohio State University Eye Physicians & Surgeons-Retina Division

    Dublin, Ohio, 43016

  • Duke University Eye Center

    Durham, North Carolina, 27710

  • VitreoRetinal Surgery

    Edina, Minnesota, 55435

  • The Retina Group of Washington

    Fairfax, Virginia, 22310

  • Illinois Retina Associates

    Flossmoor, Illinois, 60422

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33334

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Vision Research Foundation/Associated Retinal Consultants, P.C.

    Grand Rapids, Michigan, 49546

  • Long Island Vitreoretinal Consultants

    Great Neck, New York, 11021

  • Ingalls Memorial Hospital/Illinois Retina Associates

    Harvey, Illinois, 60426

  • Retina and Vitreous of Texas

    Houston, Texas, 77025

  • Vitreoretinal Consultants

    Houston, Texas, 77030

  • Midwest Eye Institute

    Indianapolis, Indiana, 46280

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Illinois Retina Associates

    Joliet, Illinois, 60435

  • Southeastern Retina Associates

    Knoxville, Tennessee, 37920

  • Southeastern Retina Associates

    Knoxville, Tennessee, 38909

  • Retina Associates of Cleveland, Inc.

    Lakewood, Ohio, 44107

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • University of Louisville School of Medicine

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Retina Consultants of Arizona

    Mesa, Arizona, 85210

  • Charlotte Eye,Ear, Nose & Throat Associates

    Monroe, North Carolina, 28112

  • Retina Vitreous Associates, P.C.

    Nashville, Tennessee, 37203

  • Retina Vitreous Center, PA

    New Brunswick, New Jersey, 08901

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Retina Diagnostic and Treatment Associates, LLC

    Philadelphia, Pennsylvania, 19107

  • Retinal Consultants of Arizona

    Phoenix, Arizona, 85064

  • Retina Vitreous Consultants

    Pittsburgh, Pennsylvania, 15213

  • Retina Northwest, P.C.

    Portland, Oregon, 97210

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Long Island Vitreoretinal Consultants

    Riverhead, New York, 11902

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Vision Research Foundation/Associated Retinal Consultants, P.C.

    Royal Oak, Michigan, 48073

  • University of California-Davis Medical Center

    Sacramento, California, 95817

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95819

  • West Coast Retina Medical Group, Inc.

    San Francisco, California, 94107

  • California Retinal Consultants

    Santa Barbara, California, 93103

  • Barnes Retina Institute

    St Louis, Missouri, 63110

  • Retina Vitreous Center, PA

    Toms River, New Jersey, 08755

  • Retina Specialists

    Towson, Maryland, 21204

  • Vision research Foundation/Associated Retinal Consultants. P.C.

    Traverse City, Michigan, 49684

  • Retina Associates Southwest, P.C.

    Tucson, Arizona, 85710

  • West Coast Retina Medical Group, Inc.

    Walnut Creek, California, 94596

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
bevacizumab, ranibizumab, choroidal neovascularization
Medical subject headings
Macular Degeneration, Choroidal Neovascularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ranibizumabDrug

    Also called Lucentis

    • 0.5 mg (0.05 mL)intravitreal injection

  • bevacizumabDrug

    Also called Avastin

    • 1.25 mg (0.05 mL)intravitreal injection
Study groups in NCT00593450
Study groupRoleWhat they receive
1Active comparatorLucentis® 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.
Receives: Drug: ranibizumab
2ExperimentalAvastin® 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.
Receives: Drug: bevacizumab
3ExperimentalLucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Receives: Drug: ranibizumab
4ExperimentalAvastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Receives: Drug: bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 1 Year

Secondary outcomes (15)

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

    Measured: Baseline and 1 Year

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

    Measured: at 1 Year

  3. 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.

    Measured: at 1 Year

  4. Number of Treatments

    Cumulative over the 1 year of trial

    Measured: 1 Year

  5. Average Cost of Drug/Patient

    Measured: at 1 Year

  6. Total Thickness at Fovea

    Measured: at 1 Year

  7. Total Thickness Change From Baseline at Fovea

    Measured: Baseline and 1 Year

  8. Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea

    Measured: at 1 Year

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

    Measured: Baseline and 1 Year

  10. Fluid on Optical Coherence Tomography

    Measured: at 1 Year

  11. Dye Leakage on Angiogram

    Measured: at 1 Year

  12. Area of Lesion

    Measured: at 1 Year

  13. Area of Lesion Change From Baseline

    Measured: Baseline and 1 Year

  14. Change in Systolic Blood Pressure From Baseline

    Measured: Baseline and 1 Year

  15. Change in Diastolic Blood Pressure From Baseline

    Measured: Baseline and 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionDec 2010
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
1,208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00593450
Sponsor's protocol ID
NEI-137
Other IDs
U10EY017823
Status last verified
Jul 2017
First submitted
3 Jan 2008
Last updated
21 Aug 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Available at https://hyperprod.cceb.med.upenn.edu/catt/catt\_index.php

Publications

  • Martin DF, Maguire MG, Fine SL. Identifying and eliminating the roadblocks to comparative-effectiveness research. N Engl J Med. 2010 Jul 8;363(2):105-7. doi: 10.1056/NEJMp1001201. Epub 2010 Jun 2. No abstract available.

    PubMed 20519677

  • CATT Research Group; Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28.

    PubMed 21526923

  • Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group; Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, Grunwald JE, Toth C, Redford M, Ferris FL 3rd. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology. 2012 Jul;119(7):1388-98. doi: 10.1016/j.ophtha.2012.03.053. Epub 2012 May 1.

    PubMed 22555112

  • Grunwald JE, Daniel E, Ying GS, Pistilli M, Maguire MG, Alexander J, Whittock-Martin R, Parker CR, Sepielli K, Blodi BA, Martin DF; CATT Research Group. Photographic assessment of baseline fundus morphologic features in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2012 Aug;119(8):1634-41. doi: 10.1016/j.ophtha.2012.02.013. Epub 2012 Apr 17.

    PubMed 22512984

  • Martin DF, Maguire MG, Fine SL. Bevacizumab: not as good with more adverse reactions? Response. Clin Exp Ophthalmol. 2011 Sep-Oct;39(7):718-20. doi: 10.1111/j.1442-9071.2011.02703.x. No abstract available.

    PubMed 22452699

  • Cheung CM, Wong TY. Ranibizumab and bevacizumab for AMD. N Engl J Med. 2011 Dec 8;365(23):2237; author reply 2237. doi: 10.1056/NEJMc1107895. No abstract available.

    PubMed 22150050

  • DeCroos FC, Toth CA, Stinnett SS, Heydary CS, Burns R, Jaffe GJ; CATT Research Group. Optical coherence tomography grading reproducibility during the Comparison of Age-related Macular Degeneration Treatments Trials. Ophthalmology. 2012 Dec;119(12):2549-57. doi: 10.1016/j.ophtha.2012.06.040. Epub 2012 Aug 28.

    PubMed 22939114

  • Ying GS, Huang J, Maguire MG, Jaffe GJ, Grunwald JE, Toth C, Daniel E, Klein M, Pieramici D, Wells J, Martin DF; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Baseline predictors for one-year visual outcomes with ranibizumab or bevacizumab for neovascular age-related macular degeneration. Ophthalmology. 2013 Jan;120(1):122-9. doi: 10.1016/j.ophtha.2012.07.042. Epub 2012 Oct 6.

    PubMed 23047002

  • Hagstrom SA, Ying GS, Pauer GJT, Sturgill-Short GM, Huang J, Callanan DG, Kim IK, Klein ML, Maguire MG, Martin DF; Comparison of AMD Treatments Trials Research Group. Pharmacogenetics for genes associated with age-related macular degeneration in the Comparison of AMD Treatments Trials (CATT). Ophthalmology. 2013 Mar;120(3):593-599. doi: 10.1016/j.ophtha.2012.11.037. Epub 2013 Jan 18.

    PubMed 23337555

  • Jaffe GJ, Martin DF, Toth CA, Daniel E, Maguire MG, Ying GS, Grunwald JE, Huang J; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Macular morphology and visual acuity in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2013 Sep;120(9):1860-70. doi: 10.1016/j.ophtha.2013.01.073. Epub 2013 May 1.

    PubMed 23642377

  • Maguire MG, Daniel E, Shah AR, Grunwald JE, Hagstrom SA, Avery RL, Huang J, Martin RW, Roth DB, Castellarin AA, Bakri SJ, Fine SL, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials (CATT Research Group). Incidence of choroidal neovascularization in the fellow eye in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2013 Oct;120(10):2035-41. doi: 10.1016/j.ophtha.2013.03.017. Epub 2013 May 22.

    PubMed 23706946

  • Daniel E, Toth CA, Grunwald JE, Jaffe GJ, Martin DF, Fine SL, Huang J, Ying GS, Hagstrom SA, Winter K, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Risk of scar in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2014 Mar;121(3):656-66. doi: 10.1016/j.ophtha.2013.10.019. Epub 2013 Dec 4.

    PubMed 24314839

  • Grunwald JE, Daniel E, Huang J, Ying GS, Maguire MG, Toth CA, Jaffe GJ, Fine SL, Blodi B, Klein ML, Martin AA, Hagstrom SA, Martin DF; CATT Research Group. Risk of geographic atrophy in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2014 Jan;121(1):150-161. doi: 10.1016/j.ophtha.2013.08.015. Epub 2013 Sep 29.

    PubMed 24084496

  • Hagstrom SA, Ying GS, Pauer GJ, Sturgill-Short GM, Huang J, Maguire MG, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group. VEGFA and VEGFR2 gene polymorphisms and response to anti-vascular endothelial growth factor therapy: comparison of age-related macular degeneration treatments trials (CATT). JAMA Ophthalmol. 2014 May;132(5):521-7. doi: 10.1001/jamaophthalmol.2014.109.

    PubMed 24652518

  • Kim BJ, Ying GS, Huang J, Levy NE, Maguire MG; CATT Research Group. Sporadic visual acuity loss in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Am J Ophthalmol. 2014 Jul;158(1):128-135.e10. doi: 10.1016/j.ajo.2014.04.004. Epub 2014 Apr 13.

    PubMed 24727261

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ranibizumab and bevacizumab in people with Age Related Macular Degeneration, run by University of Pennsylvania at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Visual-acuity Score (Continuous) (time frame: Baseline and 1 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00593450, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.

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