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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Macular Laser Photocoagulation
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Macular Laser Photocoagulation Treatment (Control)

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

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

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
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)
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
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.
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.

Full Information

First Posted
May 27, 2011
Last Updated
April 25, 2016
Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01363440
Brief Title
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
Acronym
VISTA DME
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema, Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
466 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macular Laser Photocoagulation Treatment (Control)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Arm Type
Experimental
Arm Description
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
Arm Title
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
Arm Type
Experimental
Arm Description
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Intervention Type
Procedure
Intervention Name(s)
Macular Laser Photocoagulation
Intervention Description
Laser therapy
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline and Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Time Frame
Baseline and Week 52
Title
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Time Frame
Baseline and Week 52
Title
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
Description
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)
Time Frame
Baseline and Week 52
Title
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
Time Frame
Baseline and Week 52
Title
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
Description
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.
Time Frame
Baseline and Week 52
Title
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
Description
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.
Time Frame
Baseline and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Arcadia
State/Province
California
Country
United States
City
Beverly Hills
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California
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United States
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La Jolla
State/Province
California
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United States
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Mountain View
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California
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Oakland
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California
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United States
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Palm Desert
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California
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Sacramento
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California
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United States
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San Francisco
State/Province
California
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United States
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Santa Barbara
State/Province
California
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United States
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Torrance
State/Province
California
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United States
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Colorado Springs
State/Province
Colorado
Country
United States
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Golden
State/Province
Colorado
Country
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New London
State/Province
Connecticut
Country
United States
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Fort Lauderdale
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Florida
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United States
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Fort Myers
State/Province
Florida
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United States
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Miami
State/Province
Florida
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United States
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Orlando
State/Province
Florida
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United States
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Winter Haven
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Florida
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United States
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Augusta
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Georgia
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United States
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Aiea
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Hawaii
Country
United States
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Wichita
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Kansas
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United States
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Portland
State/Province
Maine
Country
United States
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Baltimore
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Maryland
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Boston
State/Province
Massachusetts
Country
United States
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Missoula
State/Province
Montana
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United States
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Las Vegas
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Nevada
Country
United States
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New Brunswick
State/Province
New Jersey
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Northfield
State/Province
New Jersey
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United States
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Teaneck
State/Province
New Jersey
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United States
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Lynbrook
State/Province
New York
Country
United States
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Orchard Park
State/Province
New York
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United States
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Rochester
State/Province
New York
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Asheville
State/Province
North Carolina
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United States
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Charlotte
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North Carolina
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Raleigh
State/Province
North Carolina
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United States
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Portland
State/Province
Oregon
Country
United States
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Kingston
State/Province
Pennsylvania
Country
United States
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Pittsburgh
State/Province
Pennsylvania
Country
United States
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Florence
State/Province
South Carolina
Country
United States
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West Columbia
State/Province
South Carolina
Country
United States
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Rapid City
State/Province
South Dakota
Country
United States
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Nashville
State/Province
Tennessee
Country
United States
City
Abilene
State/Province
Texas
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United States
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Austin
State/Province
Texas
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United States
City
Harlingen
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio (2 locations)
State/Province
Texas
Country
United States
City
The Woodlands
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35440699
Citation
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.
Results Reference
derived
PubMed Identifier
30946887
Citation
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.
Results Reference
derived
PubMed Identifier
29785301
Citation
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.
Results Reference
derived
PubMed Identifier
29051325
Citation
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.
Results Reference
derived
PubMed Identifier
28006063
Citation
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.
Results Reference
derived
PubMed Identifier
27847634
Citation
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.
Results Reference
derived

Learn more about this trial

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

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