Comparison of Age-related Macular Degeneration Treatments NCT00593450

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 all — Click 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

See also
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Completed	`NCT02556723` - Intravitreal Injections of Ziv-aflibercept for Macular Diseases	N/A
Active, not recruiting	`NCT01943396` - Treatment of AMD With Rheohemapheresis /RHF/	Phase 4
Completed	`NCT00963339` - Age-Related Macular Degeneration (AMD) - Usability Study	N/A
Completed	`NCT00376701` - Combination Therapy for Age-Related Macular Degeneration.	Phase 2
Terminated	`NCT00347165` - Intravitreal Bevacizumab for Age-Related Macular Degeneration	Phase 2
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Completed	`NCT04689789` - OCTA and Retinal Angiomatous Proliferation
Completed	`NCT02567604` - Development of Core Outcomes for Age-related Macular Degeneration (AMD) Interventions- Caregivers' Perspective
Completed	`NCT02173496` - Colour Contrast Sensitivity for the Early Detection of Wet Age-related Macular Degereration (CEDAR)
Recruiting	`NCT01991730` - Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients	N/A
Active, not recruiting	`NCT01657669` - Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results	Phase 4
Completed	`NCT00791570` - Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy	Phase 1
Completed	`NCT00776763` - Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab	Phase 2
Completed	`NCT00413829` - Immediate Effects of Lucentis® in Conjunction With Photodynamic Therapy With Visudyne® in Exudative AMD(IECOMB)	Phase 2

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (2)

Country where clinical trial is conducted

References & Publications (11)

Outcome

External Links