Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD) (VIEW1)

This study has been completed.

Sponsor:

Collaborator:

Bayer

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00509795

First received: July 31, 2007

Last updated: December 20, 2012

Last verified: December 2012

History of Changes

Purpose

This study is a phase 3, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in the US and Canada.

Condition	Intervention	Phase
Macular Degeneration	Biological: ranibizumab Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration tumor necrosis factor receptor-associated periodic syndrome X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab Aflibercept

U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.

Secondary Outcome Measures:

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.
Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF. [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.
Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF [ Time Frame: Baseline and at Week 52 ] [ Designated as safety issue: No ]
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF) [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.

Enrollment:	1217
Study Start Date:	August 2007
Study Completion Date:	July 2011
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: ranibizumab 0.5mg Q4	Biological: ranibizumab Participants received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. Other Name: Lucentis
Experimental: aflibercept injection 2.0mg Q4	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321) Participants received a 2.0mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. Other Names: VEGF Trap-Eye BAY86-5321
Experimental: aflibercept injection 0.5mg Q4	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321) Participants received a 0.5mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. Other Names: VEGF Trap-Eye BAY86-5321
Experimental: aflibercept injection 2.0mg Q8	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321) Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. Other Names: VEGF Trap-Eye BAY86-5321

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed Informed Consent.
Men and women ≥ 50 years of age.
Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) of: letter score of 73 to 25 (20/40 to 20/320) in the study eye at 4 meters.
Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member. See Appendix J.4) understand and willing to sign the informed consent form.

Key

Exclusion Criteria:

Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
Any prior treatment with anti-VEGF agents in the study eye.
Total lesion size > 12 disc areas (30.5 mm^2, including blood, scars and neovascularization) as assessed by FA in the study eye.
Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible CNV.)
Scar or fibrosis, making up > 50% of total lesion in the study eye.
Scar, fibrosis, or atrophy involving the center of the fovea.
Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
Presence of other causes of CNV in the study eye.
History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either eye.
Prior vitrectomy in the study eye.
History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
Any history of macular hole of stage 2 and above in the study eye.
Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509795

Hide Study Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35205

Birmingham, Alabama, United States, 35223
United States, Arizona

Phoenix, Arizona, United States, 85014

Phoenix, Arizona, United States, 85020

Tucson, Arizona, United States, 85704

Tucson, Arizona, United States, 85710
United States, California

Beverly Hills, California, United States, 90211

Campbell, California, United States, 95008

Fullerton, California, United States, 92835

Glendale, California, United States, 91203

Irvine, California, United States, 92697

La Jolla, California, United States, 92037

Loma Linda, California, United States, 92354

Los Angeles, California, United States, 90033

Los Angeles, California, United States, 90048

Menlo Park, California, United States, 94025

Mountain View, California, United States, 94040

Oakland, California, United States, 94609

Palm Springs, California, United States, 92262

Pasadena, California, United States, 91105

Poway, California, United States, 92064

Sacramento, California, United States, 95819

San Diego, California, United States, 92120

San Francisco, California, United States, 94107

Santa Ana, California, United States, 92705

Torrance, California, United States, 90503

Ventura, California, United States, 93003

Westlake Village, California, United States, 91361

Yorba Linda, California, United States, 92887
United States, Colorado

Aurora, Colorado, United States, 80045

Denver, Colorado, United States, 80205

Denver, Colorado, United States, 80230
United States, Connecticut

Bridgeport, Connecticut, United States, 06606

Hamden, Connecticut, United States, 06518

New Haven, Connecticut, United States, 06510

New London, Connecticut, United States, 06320
United States, Florida

Altamonte Springs, Florida, United States, 32701

Boynton Beach, Florida, United States, 33426

Fort Myers, Florida, United States, 33907

Ft. Lauderdale, Florida, United States, 33351

Ft. Myers, Florida, United States, 33912

Gainesville, Florida, United States, 32610

Jacksonville, Florida, United States, 32224

Miami, Florida, United States, 33136

Miami, Florida, United States, 33143

Mount Dora, Florida, United States, 32757

Orlando, Florida, United States, 32803

Orlando, Florida, United States, 32806

Oscala, Florida, United States, 34472

Palm Beach Gardens, Florida, United States, 33410

Pensacola, Florida, United States, 32503

Sarasota, Florida, United States

Stuart, Florida, United States, 34994

Tampa, Florida, United States, 33612

Winter Haven, Florida, United States, 33880
United States, Georgia

Augusta, Georgia, United States, 30909
United States, Hawaii

Aiea, Hawaii, United States, 96701

Honolulu, Hawaii, United States, 96813
United States, Illinois

Oak Brook, Illinois, United States, 60523
United States, Indiana

Fort Wayne, Indiana, United States, 46804

Indianapolis, Indiana, United States, 46202

Indianapolis, Indiana, United States, 46260

Indianapolis, Indiana, United States, 46280

New Albany, Indiana, United States, 47150
United States, Iowa

Iowa City, Iowa, United States, 52242-1091
United States, Kansas

Wichita, Kansas, United States, 67214
United States, Kentucky

Louisville, Kentucky, United States, 40202

Louisville, Kentucky, United States, 40207

Paducah, Kentucky, United States, 42001
United States, Louisiana

New Orleans, Louisiana, United States, 70115

New Orleans, Louisiana, United States, 70121

Shreveport, Louisiana, United States, 71105
United States, Maine

Bangor, Maine, United States, 04401

Portland, Maine, United States, 04102
United States, Maryland

Baltimore, Maryland, United States, 21209

Baltimore, Maryland, United States, 21287

Chevy Chase, Maryland, United States, 20815

Hagerstown, Maryland, United States, 21740

Towson, Maryland, United States, 21204
United States, Massachusetts

Boston, Massachusetts, United States, 02111

Boston, Massachusetts, United States, 02114

Boston, Massachusetts, United States, 02215

Boston, Massachusetts, United States

Peabody, Massachusetts, United States, 01960
United States, Michigan

Ann Arbor, Michigan, United States, 48105

Battle Creek, Michigan, United States, 49015

Detroit, Michigan, United States, 48202

Grand Rapids, Michigan, United States, 49525

Jackson, Michigan, United States, 49201

Royal Oak, Michigan, United States, 48073

Southfield, Michigan, United States, 48034

West Bloomfield, Michigan, United States, 48322
United States, Minnesota

Edina, Minnesota, United States, 55435

Minneapolis, Minnesota, United States, 55404

Rochester, Minnesota, United States, 55905
United States, Missouri

Florissant, Missouri, United States, 63031

Kansas City, Missouri, United States, 64108

Kansas City, Missouri, United States, 64111

Springfield, Missouri, United States, 65804

St. Louis, Missouri, United States, 63110
United States, Montana

Missoula, Montana, United States, 59801
United States, Nebraska

Lincoln, Nebraska, United States, 68506

Omaha, Nebraska, United States, 68131
United States, Nevada

Las Vegas, Nevada, United States, 89144
United States, New Jersey

Lawrenceville, New Jersey, United States, 08648

New Brunswick, New Jersey, United States, 08901

Northfield, New Jersey, United States, 08225

Teaneck, New Jersey, United States, 07666

Toms River, New Jersey, United States, 08753
United States, New Mexico

Albuquerque, New Mexico, United States, 87106
United States, New York

Albany, New York, United States, 12206

Brooklyn, New York, United States, 11223

Lynbrook, New York, United States, 11563

New York, New York, United States, 10003

New York, New York, United States, 10021

New York, New York, United States, 10032

Poughkeepsie, New York, United States, 12601

Rochester, New York, United States, 14620

Rochester, New York, United States, 14642

Slingerlands, New York, United States, 12159

Syracuse, New York, United States, 13224
United States, North Carolina

Asheville, North Carolina, United States, 28803

Charlotte, North Carolina, United States, 28210

Raleigh, North Carolina, United States, 27607

Southern Pines, North Carolina, United States, 28387

Winston-Salem, North Carolina, United States, 27157
United States, Ohio

Cincinnati, Ohio, United States, 45202

Cincinnati, Ohio, United States, 45242

Columbus, Ohio, United States, 43215

Toledo, Ohio, United States, 43608
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73104
United States, Oregon

Ashland, Oregon, United States, 97520

Portland, Oregon, United States, 97210

Portland, Oregon, United States, 97227

Salem, Oregon, United States, 97302
United States, Pennsylvania

Kingston, Pennsylvania, United States, 18704

Philadelphia, Pennsylvania, United States, 19107

Philadelphia, Pennsylvania, United States, 19124

Philadelphia, Pennsylvania, United States, 19104

Pittsberg, Pennsylvania, United States, 15231

Pittsburgh, Pennsylvania, United States, 15212

Pittsburgh, Pennsylvania, United States, 15213

West Mifflin, Pennsylvania, United States, 15122

Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island

Providence, Rhode Island, United States, 02903-4928
United States, South Carolina

Charleston, South Carolina, United States, 29414

Columbia, South Carolina, United States, 29223

Greenville, South Carolina, United States, 29605

West Columbia, South Carolina, United States, 29169
United States, South Dakota

Rapid City, South Dakota, United States, 57701
United States, Tennessee

Memphis, Tennessee, United States, 38119

Memphis, Tennessee, United States, 38120

Nashville, Tennessee, United States, 37203
United States, Texas

Abilene, Texas, United States, 79606

Austin, Texas, United States, 78705

Corpus Cristi, Texas, United States, 78413

Dallas, Texas, United States, 75390

DeSoto, Texas, United States, 75115

Ft. Worth, Texas, United States, 76102

Ft. Worth, Texas, United States, 76104

Galveston, Texas, United States, 77555

Houston, Texas, United States, 77030

McAllen, Texas, United States, 78503

Odessa, Texas, United States, 79761

San Antonio, Texas, United States, 78240
United States, Utah

Salt Lake City, Utah, United States, 84107

Salt Lake City, Utah, United States, 84132
United States, Vermont

Burlington, Vermont, United States, 05401
United States, Virginia

Charlottesville, Virginia, United States, 22908

Fairfax, Virginia, United States, 22031

Richmond, Virginia, United States, 23221
United States, Washington

Seattle, Washington, United States, 98104

Silverdale, Washington, United States, 98383
United States, Wisconsin

Madison, Wisconsin, United States, 53715

Madison, Wisconsin, United States, 58705

Milwaukee, Wisconsin, United States, 53226
Canada, Alberta

Calgary, Alberta, Canada, T3E 7MB
Canada, British Columbia

Vancouver, British Columbia, Canada, V5Z 3N9

Victoria, British Columbia, Canada, V8V 1B3
Canada, Nova Scotia

Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario

London, Ontario, Canada, N6A 4G5

Mississauga, Ontario, Canada, L4W 1W9

Ottawa, Ontario, Canada, K1H8L6

Toronto, Ontario, Canada, M5C 2T2

Toronto, Ontario, Canada, M4N3M5
Canada, Quebec

Montreal, Quebec, Canada, H1T 2M4

Montreal, Quebec, Canada, H3A 1A1
Canada, Saskatchewan

Regina, Saskatchewan, Canada, S4T 1A5

Sponsors and Collaborators

Regeneron Pharmaceuticals

Bayer

Investigators

Study Director:

Robert Vitti, MD

Regeneron Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00509795 History of Changes
Other Study ID Numbers:	VGFT-OD-0605
Study First Received:	July 31, 2007
Results First Received:	December 16, 2011
Last Updated:	December 20, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Additional relevant MeSH terms:

Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013

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