Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema

NCT01363440 | Completed Phase 3 Results DMC

• 1 other identifier: VGFT-OD-1009
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 51

Brief Summary

The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)

  Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.

  Baseline and Week 52

Secondary Outcomes (6)

• Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF

  Baseline and Week 52

• Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF

  Baseline and Week 52

• Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF

  Baseline and Week 52

• Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF

  Baseline and Week 52

• Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF

  Baseline and Week 52

Study Arms (3)

Macular Laser Photocoagulation Treatment (Control)

ACTIVE COMPARATOR

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.

Procedure: Macular Laser Photocoagulation

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4

EXPERIMENTAL

Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.

Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8

EXPERIMENTAL

Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.

Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)

Interventions

Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) DRUG

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4; Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8

Macular Laser Photocoagulation PROCEDURE

Laser therapy

Macular Laser Photocoagulation Treatment (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years with type 1 or 2 diabetes mellitus
• 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

You may not qualify if:

• Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Bayer: collaborator

Study Sites (51)

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Arcadia, California, United States

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Beverly Hills, California, United States

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La Jolla, California, United States

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Mountain View, California, United States

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Oakland, California, United States

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Palm Desert, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Santa Barbara, California, United States

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Torrance, California, United States

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Colorado Springs, Colorado, United States

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Golden, Colorado, United States

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New London, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Winter Haven, Florida, United States

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Augusta, Georgia, United States

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‘Aiea, Hawaii, United States

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Wichita, Kansas, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Missoula, Montana, United States

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Las Vegas, Nevada, United States

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New Brunswick, New Jersey, United States

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Northfield, New Jersey, United States

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Teaneck, New Jersey, United States

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Lynbrook, New York, United States

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Orchard Park, New York, United States

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Rochester, 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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Raleigh, North Carolina, United States

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Portland, Oregon, United States

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Kingston, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Florence, 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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Nashville, Tennessee, United States

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Abilene, Texas, United States

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Austin, Texas, United States

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Harlingen, Texas, United States

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Houston, Texas, United States

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San Antonio (2 Locations), Texas, United States

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The Woodlands, Texas, United States

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Salt Lake City, Utah, United States

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Related Publications (8)

• Matar K, Indurkar A, Yordi S, Cetin H, Reese JL, Srivastava SK, Ehlers JP. Expanding insights from the VISTA phase III trial: longitudinal comparative assessment of ellipsoid zone integrity and volumetric fluid dynamics. Sci Rep. 2025 Dec 5;15(1):43222. doi: 10.1038/s41598-025-27350-w.

  PMID: 41350590 DERIVED

• 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.

  PMID: 36265076 DERIVED

• 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.

  PMID: 35440699 DERIVED

• 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.

  PMID: 30946887 DERIVED

• 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.

  PMID: 29785301 DERIVED

• 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.

  PMID: 29051325 DERIVED

• 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.

  PMID: 28006063 DERIVED

• 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.

  PMID: 27847634 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron

clinicaltrials@regeneron.com

914 847 7000

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 1, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: November 1, 2014
• Last Updated: May 30, 2016
• Results First Posted: April 20, 2015

Record last verified: 2016-04

Locations

US (51)