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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00593450
Other study ID # NEI-137
Secondary ID U10EY017823
Status Active, not recruiting
Phase Phase 3
First received January 3, 2008
Last updated May 26, 2015
Start date February 2008
Est. completion date July 2016

Study information

Verified date May 2015
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1208
Est. completion date July 2016
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ranibizumab
• 0.5 mg (0.05 mL)intravitreal injection
bevacizumab
• 1.25 mg (0.05 mL)intravitreal injection

Locations

Country Name City State
United States Texas Retina Associates Arlington Texas
United States Emory Eye Center Atlanta Georgia
United States California Retina Consultants Bakersfield California
United States Elman Retina Group, P.A. Baltimore Maryland
United States Retina Associates of Cleveland Beachwood Ohio
United States Retina-Vitreous Associates Medical Group Beverly Hills California
United States Harvard Vanguard Medical Associates Boston Massachusetts
United States Massachusetts Eye & Ear Infirmary Boston Massachusetts
United States Opthalmic Consultants of Boston Boston Massachusetts
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Charlotte Eye, Ear, nose & Throat Associates Charlotte North Carolina
United States The Retina Group of Washington Chevy Chase Maryland
United States Texas Retina Associates Dallas Texas
United States Colorado Retina Associates Denver Colorado
United States Ohio State University Eye Physicians & Surgeons-Retina Division Dublin Ohio
United States Duke University Eye Center Durham North Carolina
United States VitreoRetinal Surgery Edina Minnesota
United States The Retina Group of Washington Fairfax Virginia
United States Illinois Retina Associates Flossmoor Illinois
United States Retina Group of Florida Fort Lauderdale Florida
United States National Ophthalmic Research Institute Fort Myers Florida
United States Vision Research Foundation/Associated Retinal Consultants, P.C. Grand Rapids Michigan
United States Long Island Vitreoretinal Consultants Great Neck New York
United States Ingalls Memorial Hospital/Illinois Retina Associates Harvey Illinois
United States Retina and Vitreous of Texas Houston Texas
United States Vitreoretinal Consultants Houston Texas
United States Midwest Eye Institute Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Illinois Retina Associates Joliet Illinois
United States Southeastern Retina Associates Knoxville Tennessee
United States Southeastern Retina Associates Knoxville Tennessee
United States Retina Associates of Cleveland, Inc. Lakewood Ohio
United States Retina Associates of Kentucky Lexington Kentucky
United States University of Louisville School of Medicine Louisville Kentucky
United States University of Wisconsin Madison Wisconsin
United States Retina Consultants of Arizona Mesa Arizona
United States Charlotte Eye,Ear, Nose & Throat Associates Monroe North Carolina
United States Retina Vitreous Associates, P.C. Nashville Tennessee
United States Retina Vitreous Center, PA New Brunswick New Jersey
United States Dean A. McGee Eye Institute Oklahoma City Oklahoma
United States Retina Diagnostic and Treatment Associates, LLC Philadelphia Pennsylvania
United States Retinal Consultants of Arizona Phoenix Arizona
United States Retina Vitreous Consultants Pittsburgh Pennsylvania
United States Casey Eye Institute Portland Oregon
United States Retina Northwest, P.C. Portland Oregon
United States Long Island Vitreoretinal Consultants Riverhead New York
United States Mayo Clinic Rochester Minnesota
United States Vision Research Foundation/Associated Retinal Consultants, P.C. Royal Oak Michigan
United States Retinal Consultants Medical Group, Inc. Sacramento California
United States University of California-Davis Medical Center Sacramento California
United States West Coast Retina Medical Group, Inc. San Francisco California
United States California Retinal Consultants Santa Barbara California
United States Barnes Retina Institute St. Louis Missouri
United States Retina Vitreous Center, PA Toms River New Jersey
United States Retina Specialists Towson Maryland
United States Vision research Foundation/Associated Retinal Consultants. P.C. Traverse City Michigan
United States Retina Associates Southwest, P.C. Tucson Arizona
United States West Coast Retina Medical Group, Inc. Walnut Creek California
United States Palmetto Retina Center West Columbia South Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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 — View Citation

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 — View Citation

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 Macul — View Citation

Hagstrom SA, Ying GS, Pauer GJ, 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 Compar — View Citation

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 — View Citation

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 ne — View Citation

Martin DF, Maguire MG, Fine SL. Bevacizumab: not as good with more adverse reactions? Response. Clin Experiment Ophthalmol. 2011 Sep-Oct;39(7):718-20. doi: 10.1111/j.1442-9071.2011.02703.x. — View Citation

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. — View Citation

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

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 ranibiz — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline and 1 Year No
Secondary Change From Baseline Visual-acuity Score (Frequency) Baseline and 1 Year No
Secondary Visual-acuity Score and Snellen Equivalent (Frequency) at 1 Year No
Secondary 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.
at 1 Year No
Secondary Number of Treatments Cumulative over the 1 year of trial 1 Year No
Secondary Average Cost of Drug/Patient at 1 Year No
Secondary Total Thickness at Fovea at 1 Year No
Secondary Total Thickness Change From Baseline at Fovea Baseline and 1 Year No
Secondary Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea at 1 Year No
Secondary Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea Baseline and 1 Year No
Secondary Fluid on Optical Coherence Tomography at 1 Year No
Secondary Dye Leakage on Angiogram at 1 Year No
Secondary Area of Lesion at 1 Year No
Secondary Area of Lesion Change From Baseline Baseline and 1 Year No
Secondary Change in Systolic Blood Pressure From Baseline Baseline and 1 Year No
Secondary Change in Diastolic Blood Pressure From Baseline Baseline and 1 Year No
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