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Macular DegenerationPhase 3VIEW1NCT00509795

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

A Phase 3 study testing ranibizumab and aflibercept injection (VEGF Trap-Eye, BAY86-5321) in people with Macular Degeneration, run by Regeneron Pharmaceuticals at 188 sites in 2 countries.

Completed

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

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
ranibizumab and aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,217 participants
Where
188 sitesin 2 countries
Study dates
Aug 2007to Jul 2011
Phase
Phase 3

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

  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

188 sites in 2 countries.

188 sites in 2 countries

United States176 sites

  • Study site

    ‘Aiea, Hawaii, 96701

  • Study site

    Abilene, Texas, 79606

  • Study site

    Albany, New York, 12206

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Altamonte Springs, Florida, 32701

  • Study site

    Ann Arbor, Michigan, 48105

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Ashland, Oregon, 97520

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Austin, Texas, 78705

  • Study site

    Baltimore, Maryland, 21209

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Bangor, Maine, 04401

  • Study site

    Battle Creek, Michigan, 49015

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Birmingham, Alabama, 35223

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Boston, Massachusetts

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Brooklyn, New York, 11223

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Campbell, California, 95008

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chevy Chase, Maryland, 20815

  • Study site

    Cincinnati, Ohio, 45202

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Columbia, South Carolina, 29223

  • Study site

    Columbus, Ohio, 43215

  • Study site

    Corpus Cristi, Texas, 78413

  • Study site

    Dallas, Texas, 75390

  • Study site

    Denver, Colorado, 80205

  • Study site

    Denver, Colorado, 80230

  • Study site

    DeSoto, Texas, 75115

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Edina, Minnesota, 55435

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Fort Lauderdale, Florida, 33351

  • Study site

    Fort Myers, Florida, 33907

  • Study site

    Fort Myers, Florida, 33912

  • Study site

    Fort Wayne, Indiana, 46804

  • Study site

    Fort Worth, Texas, 76102

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fullerton, California, 92835

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Galveston, Texas, 77555

  • Study site

    Glendale, California, 91203

  • Study site

    Grand Rapids, Michigan, 49525

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Honolulu, Hawaii, 96813

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Indianapolis, Indiana, 46280

  • Study site

    Iowa City, Iowa, 52242-1091

  • Study site

    Irvine, California, 92697

  • Study site

    Jackson, Michigan, 49201

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Kansas City, Missouri, 64108

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kingston, Pennsylvania, 18704

  • Study site

    La Jolla, California, 92037

  • Study site

    Las Vegas, Nevada, 89144

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Lincoln, Nebraska, 68506

  • Study site

    Loma Linda, California, 92354

  • Study site

    Los Angeles, California, 90033

  • Study site

    Los Angeles, California, 90048

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    Lynbrook, New York, 11563

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Madison, Wisconsin, 58705

  • Study site

    McAllen, Texas, 78503

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Menlo Park, California, 94025

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33143

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Minneapolis, Minnesota, 55404

  • Study site

    Missoula, Montana, 59801

  • Study site

    Mountain View, California, 94040

  • Study site

    Mt. Dora, Florida, 32757

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Albany, Indiana, 47150

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    New Haven, Connecticut, 06510

  • Study site

    New London, Connecticut, 06320

  • Study site

    New Orleans, Louisiana, 70115

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10003

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10032

  • Study site

    Northfield, New Jersey, 08225

  • Study site

    Oak Brook, Illinois, 60523

  • Study site

    Oakland, California, 94609

  • Study site

    Odessa, Texas, 79761

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Orlando, Florida, 32803

  • Study site

    Orlando, Florida, 32806

  • Study site

    Oscala, Florida, 34472

  • Study site

    Paducah, Kentucky, 42001

  • Study site

    Palm Beach Gardens, Florida, 33410

  • Study site

    Palm Springs, California, 92262

  • Study site

    Pasadena, California, 91105

  • Study site

    Peabody, Massachusetts, 01960

  • Study site

    Pensacola, Florida, 32503

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Philadelphia, Pennsylvania, 19124

  • Study site

    Phoenix, Arizona, 85014

  • Study site

    Phoenix, Arizona, 85020

  • Study site

    Pittsberg, Pennsylvania, 15231

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Portland, Maine, 04102

  • Study site

    Portland, Oregon, 97210

  • Study site

    Portland, Oregon, 97227

  • Study site

    Poughkeepsie, New York, 12601

  • Study site

    Poway, California, 92064

  • Study site

    Providence, Rhode Island, 02903-4928

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Richmond, Virginia, 23221

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rochester, New York, 14620

  • Study site

    Rochester, New York, 14642

  • Study site

    Royal Oak, Michigan, 48073

  • Study site

    Sacramento, California, 95819

  • Study site

    Salem, Oregon, 97302

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    Salt Lake City, Utah, 84132

  • Study site

    San Antonio, Texas, 78240

  • Study site

    San Diego, California, 92120

  • Study site

    San Francisco, California, 94107

  • Study site

    Santa Ana, California, 92705

  • Study site

    Sarasota, Florida

  • Study site

    Seattle, Washington, 98104

  • Study site

    Shreveport, Louisiana, 71105

  • Study site

    Silverdale, Washington, 98383

  • Study site

    Slingerlands, New York, 12159

  • Study site

    Southern Pines, North Carolina, 28387

  • Study site

    Southfield, Michigan, 48034

  • Study site

    Springfield, Missouri, 65804

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Stuart, Florida, 34994

  • Study site

    Syracuse, New York, 13224

  • Study site

    Tampa, Florida, 33612

  • Study site

    Teaneck, New Jersey, 07666

  • Study site

    Toledo, Ohio, 43608

  • Study site

    Toms River, New Jersey, 08753

  • Study site

    Torrance, California, 90503

  • Study site

    Towson, Maryland, 21204

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Ventura, California, 93003

  • Study site

    West Bloomfield, Michigan, 48322

  • Study site

    West Columbia, South Carolina, 29169

  • Study site

    West Mifflin, Pennsylvania, 15122

  • Study site

    Westlake Village, California, 91361

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Winston-Salem, North Carolina, 27157

  • Study site

    Winter Haven, Florida, 33880

  • Study site

    Wyomissing, Pennsylvania, 19610

  • Study site

    Yorba Linda, California, 92887

Other trials in United States

Canada12 sites

  • Study site

    Calgary, Alberta, T3E 7MB

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    London, Ontario, N6A 4G5

  • Study site

    Mississauga, Ontario, L4W 1W9

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Ottawa, Ontario, K1H8L6

  • Study site

    Regina, Saskatchewan, S4T 1A5

  • Study site

    Toronto, Ontario, M4N3M5

  • Study site

    Toronto, Ontario, M5C 2T2

  • Study site

    Vancouver, British Columbia, V5Z 3N9

  • Study site

    Victoria, British Columbia, V8V 1B3

Other trials in Canada

About this study

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

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.

Being tested
ranibizumab, aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Medical subject headings
Macular Degeneration

What participants receive

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

  • ranibizumabBiological

    Also called Lucentis

    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.

  • aflibercept injection (VEGF Trap-Eye, BAY86-5321)Biological

    Also called 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.

  • aflibercept injection (VEGF Trap-Eye, BAY86-5321)Biological

    Also called 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.

  • aflibercept injection (VEGF Trap-Eye, BAY86-5321)Biological

    Also called 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.

Study groups in NCT00509795
Study groupRoleWhat they receive
ranibizumab 0.5mg Q4Active comparatorNot described
Receives: Biological: ranibizumab
aflibercept injection 2.0mg Q4ExperimentalNot described
Receives: Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection 0.5mg Q4ExperimentalNot described
Receives: Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection 2.0mg Q8ExperimentalNot described
Receives: Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

What is being measured

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

  1. Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)

    Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.

    Measured: Baseline and at week 52

Secondary outcomes (4)

  1. 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

    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.

    Measured: Baseline and at week 52

  2. Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.

    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.

    Measured: Baseline and at week 52

  3. Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF

    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.

    Measured: Baseline and at Week 52

  4. Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)

    CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.

    Measured: Baseline and at week 52

Timeline

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

  1. First posted1 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionSep 2010
  4. Study completionJul 2011

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00509795
Sponsor's protocol ID
VGFT-OD-0605
Acronym
VIEW1
Status last verified
Dec 2012
First submitted
31 Jul 2007
Last updated
28 Dec 2012
Data monitoring committee
Yes

Publications

  • Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.

    PubMed 32374423

  • Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11.

    PubMed 31826853

  • Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6.

    PubMed 25439429

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