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Diabetic Macular EdemaPhase 3VISTA DMENCT01363440

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

A Phase 3 study testing Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) and Macular Laser Photocoagulation in people with Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 51 sites in United States.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) and Macular Laser Photocoagulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
466 participants
Where
51 sitesUnited States
Study dates
May 2011to Nov 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The following is an abbreviated list of inclusion criteria:
  • 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

Who cannot join

  • The following is an abbreviated list of exclusion criteria:
  • 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

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • Study site

    ‘Aiea, Hawaii

  • Study site

    Abilene, Texas

  • Study site

    Arcadia, California

  • Study site

    Asheville, North Carolina

  • Study site

    Augusta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Beverly Hills, California

  • Study site

    Boston, Massachusetts

  • Study site

    Charlotte, North Carolina

  • Study site

    Colorado Springs, Colorado

  • Study site

    Florence, South Carolina

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Myers, Florida

  • Study site

    Golden, Colorado

  • Study site

    Harlingen, Texas

  • Study site

    Houston, Texas

  • Study site

    Kingston, Pennsylvania

  • Study site

    La Jolla, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Lynbrook, New York

  • Study site

    Miami, Florida

  • Study site

    Missoula, Montana

  • Study site

    Mountain View, California

  • Study site

    Nashville, Tennessee

  • Study site

    New Brunswick, New Jersey

  • Study site

    New London, Connecticut

  • Study site

    Northfield, New Jersey

  • Study site

    Oakland, California

  • Study site

    Orchard Park, New York

  • Study site

    Orlando, Florida

  • Study site

    Palm Desert, California

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Maine

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Rapid City, South Dakota

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio (2 Locations), Texas

  • Study site

    San Francisco, California

  • Study site

    Santa Barbara, California

  • Study site

    Teaneck, New Jersey

  • Study site

    The Woodlands, Texas

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    West Columbia, South Carolina

  • Study site

    Wichita, Kansas

  • Study site

    Winter Haven, Florida

Other trials in United States

About this study

Official title: A Double-Masked, Randomized, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema

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.

Being tested
Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321), Macular Laser Photocoagulation
Keywords
Diabetic Macular Edema, Diabetic Retinopathy
Medical subject headings
Diabetic Retinopathy

What participants receive

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

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

  • Macular Laser PhotocoagulationProcedure or surgery

    Laser therapy

Study groups in NCT01363440
Study groupRoleWhat they receive
Macular Laser Photocoagulation Treatment (Control)Active comparatorParticipants 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.
Receives: Procedure: Macular Laser Photocoagulation
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4ExperimentalParticipants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
Receives: Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8ExperimentalParticipants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Receives: Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)

What is being measured

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

  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.

    Measured: Baseline and Week 52

Secondary outcomes (6)

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

    Measured: Baseline and Week 52

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

    Measured: Baseline and Week 52

  3. 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 ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)

    Measured: Baseline and Week 52

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

    Measured: Baseline and Week 52

  5. Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale 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 that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.

    Measured: Baseline and Week 52

  6. Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale 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 that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.

    Measured: Baseline and 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 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2013
  4. Study completionNov 2014

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01363440
Sponsor's protocol ID
VGFT-OD-1009
Acronym
VISTA DME
Status last verified
Apr 2016
First submitted
27 May 2011
Last updated
30 May 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41350590

  • 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.

    PubMed 36265076

  • 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.

    PubMed 35440699

  • 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.

    PubMed 30946887

  • 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.

    PubMed 29785301

  • 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.

    PubMed 29051325

  • 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.

    PubMed 28006063

  • 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.

    PubMed 27847634

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) and Macular Laser Photocoagulation in people with Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01363440, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.

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