Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
NCT ID: NCT01363440
Last Updated: 2016-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
466 participants
INTERVENTIONAL
2011-05-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Macular Laser Photocoagulation Treatment (Control)
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Macular Laser Photocoagulation
Laser therapy
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Interventions
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Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Macular Laser Photocoagulation
Laser therapy
Eligibility Criteria
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Inclusion Criteria
* Decrease in vision determined to be primarily the result of DME in the study eye
* BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion Criteria
* Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1
* Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1
* Active proliferative diabetic retinopathy (PDR) in the study eye
* Uncontrolled diabetes mellitus
* Only 1 functional eye even if that eye is otherwise eligible for the study
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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Phoenix, Arizona, United States
Tucson, Arizona, United States
Arcadia, California, United States
Beverly Hills, California, United States
La Jolla, California, United States
Mountain View, California, United States
Oakland, California, United States
Palm Desert, California, United States
Sacramento, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Torrance, California, United States
Colorado Springs, Colorado, United States
Golden, Colorado, United States
New London, Connecticut, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
‘Aiea, Hawaii, United States
Wichita, Kansas, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Missoula, Montana, United States
Las Vegas, Nevada, United States
New Brunswick, New Jersey, United States
Northfield, New Jersey, United States
Teaneck, New Jersey, United States
Lynbrook, New York, United States
Orchard Park, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Portland, Oregon, United States
Kingston, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Florence, South Carolina, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Harlingen, Texas, United States
Houston, Texas, United States
San Antonio (2 Locations), Texas, United States
The Woodlands, Texas, United States
Salt Lake City, Utah, United States
Countries
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References
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Dhoot DS, Moini H, Reed K, Silva FQ, Berliner A, Du W, Sharma S. INCIDENCE OF NEW DIABETIC MACULAR EDEMA IN FELLOW EYES OF PATIENTS IN THE VISTA AND VIVID STUDIES. Retina. 2023 Feb 1;43(2):254-262. doi: 10.1097/IAE.0000000000003658. Epub 2022 Oct 17.
Dhoot DS, Moini H, Reed K, Du W, Vitti R, Berliner AJ, Singh RP. Functional outcomes of sustained improvement on Diabetic Retinopathy Severity Scale with intravitreal aflibercept in the VISTA and VIVID trials. Eye (Lond). 2023 Jul;37(10):2020-2025. doi: 10.1038/s41433-022-02058-7. Epub 2022 Apr 19.
Wykoff CC, Shah C, Dhoot D, Coleman HR, Thompson D, Du W, Baker K, Vitti R, Berliner AJ, Metzig C, Saroj N. Longitudinal Retinal Perfusion Status in Eyes with Diabetic Macular Edema Receiving Intravitreal Aflibercept or Laser in VISTA Study. Ophthalmology. 2019 Aug;126(8):1171-1180. doi: 10.1016/j.ophtha.2019.03.040. Epub 2019 Apr 1.
Midena E, Gillies M, Katz TA, Metzig C, Lu C, Ogura Y. Impact of Baseline Central Retinal Thickness on Outcomes in the VIVID-DME and VISTA-DME Studies. J Ophthalmol. 2018 Mar 29;2018:3640135. doi: 10.1155/2018/3640135. eCollection 2018.
Staurenghi G, Feltgen N, Arnold JJ, Katz TA, Metzig C, Lu C, Holz FG; VIVID-DME and VISTA-DME study investigators. Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies. Br J Ophthalmol. 2018 Jul;102(7):954-958. doi: 10.1136/bjophthalmol-2017-310664. Epub 2017 Oct 19.
Wykoff CC, Marcus DM, Midena E, Korobelnik JF, Saroj N, Gibson A, Vitti R, Berliner AJ, Williams Liu Z, Zeitz O, Metzig C, Schmelter T, Heier JS. Intravitreal Aflibercept Injection in Eyes With Substantial Vision Loss After Laser Photocoagulation for Diabetic Macular Edema: Subanalysis of the VISTA and VIVID Randomized Clinical Trials. JAMA Ophthalmol. 2017 Feb 1;135(2):107-114. doi: 10.1001/jamaophthalmol.2016.4912.
Ziemssen F, Schlottman PG, Lim JI, Agostini H, Lang GE, Bandello F. Initiation of intravitreal aflibercept injection treatment in patients with diabetic macular edema: a review of VIVID-DME and VISTA-DME data. Int J Retina Vitreous. 2016 Jul 11;2:16. doi: 10.1186/s40942-016-0041-z. eCollection 2016.
Other Identifiers
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VGFT-OD-1009
Identifier Type: -
Identifier Source: org_study_id