Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
NCT ID: NCT04429503
Last Updated: 2025-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
660 participants
INTERVENTIONAL
2020-06-29
2024-06-18
Brief Summary
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The secondary objectives of the study are as follows:
* To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response
* To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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aflibercept Q8
Administered every 8 weeks after a loading phase
aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
High-Dose aflibercept Q12
Administered every 12 weeks after a loading phase
High-dose aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
High-Dose aflibercept Q16
Administered every 16 weeks after a loading phase
High-dose aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
Interventions
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aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
High-dose aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME
* Willing and able to comply with clinic visits and study-related procedures
* Provide informed consent signed by study participant or legally acceptable representative
Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.
Exclusion Criteria
* Active proliferative diabetic retinopathy in the study eye
* IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye
* Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time
* Treatment with ocriplasmin (JETREA®) in the study eye at any time
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Study Site
Phoenix, Arizona, United States
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Arcadia, California, United States
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Beverly Hills, California, United States
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Campbell, California, United States
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Encino, California, United States
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Fullerton, California, United States
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Huntington Beach, California, United States
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Long Beach, California, United States
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Palo Alto, California, United States
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Pasadena, California, United States
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Poway, California, United States
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Rancho Cordova, California, United States
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Riverside, California, United States
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Torrance, California, United States
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Colorado Springs, Colorado, United States
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Durango, Colorado, United States
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Lakewood, Colorado, United States
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Waterford, Connecticut, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Lakeland, Florida, United States
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Largo, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pinellas Park, Florida, United States
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Plantation, Florida, United States
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St. Petersburg, Florida, United States
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Stuart, Florida, United States
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Winter Haven, Florida, United States
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Augusta, Georgia, United States
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Marietta, Georgia, United States
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Marietta, Georgia, United States
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‘Aiea, Hawaii, United States
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Oak Forest, Illinois, United States
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Springfield, Illinois, United States
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Springfield, Illinois, United States
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Carmel, Indiana, United States
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Shawnee Mission, Kansas, United States
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Baltimore, Maryland, United States
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Hagerstown, Maryland, United States
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Boston, Massachusetts, United States
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Royal Oak, Michigan, United States
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Southaven, Mississippi, United States
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Henderson, Nevada, United States
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Bloomfield, New Jersey, United States
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Edison, New Jersey, United States
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Teaneck, New Jersey, United States
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Great Neck, New York, United States
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Liverpool, New York, United States
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New York, New York, United States
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Oceanside, New York, United States
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Shirley, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dublin, Ohio, United States
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Edmond, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Kingston, Pennsylvania, United States
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Monroeville, Pennsylvania, United States
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Beaufort, South Carolina, United States
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Ladson, South Carolina, United States
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West Columbia, South Carolina, United States
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Rapid City, South Dakota, United States
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Germantown, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Abilene, Texas, United States
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Bellaire, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Willow Park, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Morgantown, West Virginia, United States
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Calgary, Alberta, Canada
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Mississauga, Ontario, Canada
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North York, Ontario, Canada
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Sherbrooke, Quebec, Canada
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Neubrandenburg, Mecklenburg-Westfalen, Germany
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Göttingen, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Pécs, Baranya, Hungary
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Szombathely, Vas County, Hungary
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Zalaegerszeg, Zala County, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Nagakute, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Yoshida-Gun, Fukui, Japan
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Kurume, Fukuoka, Japan
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Kōriyama, Fukushima, Japan
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Hakodate, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Mito, Ibaraki, Japan
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Toride, Ibaraki, Japan
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Tsuchiura-shi, Ibaraki, Japan
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Kita-gun, Kagawa-ken, Japan
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Kawasaki, Kanagawa, Japan
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Matsumoto, Nagano, Japan
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Nagasaki, Nagasaki, Japan
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Kashihara, Nara, Japan
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Hirakata, Osaka, Japan
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Tokorozawa, Saitama, Japan
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Susono, Shizuoka, Japan
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Shimotsuke-shi, Tochigi, Japan
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Chiyoda-ku, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Ube, Yamaguchi, Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Kagoshima, , Japan
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Osaka, , Japan
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Saitama, , Japan
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Tokushima, , Japan
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Arecibo, , Puerto Rico
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Sunderland, Tyne and Wear, United Kingdom
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London, , United Kingdom
Countries
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References
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Brown DM, Boyer DS, Do DV, Wykoff CC, Sakamoto T, Win P, Joshi S, Salehi-Had H, Seres A, Berliner AJ, Leal S, Vitti R, Chu KW, Reed K, Rao R, Cheng Y, Sun W, Voronca D, Bhore R, Schmidt-Ott U, Schmelter T, Schulze A, Zhang X, Hirshberg B, Yancopoulos GD, Sivaprasad S; PHOTON Investigators. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial. Lancet. 2024 Mar 23;403(10432):1153-1163. doi: 10.1016/S0140-6736(23)02577-1. Epub 2024 Mar 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-003643-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VGFTe-HD-DME-1934
Identifier Type: -
Identifier Source: org_study_id
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