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

April 25, 2016 updated by: Regeneron Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

466

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • 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
      • Colorado Springs, Colorado, United States
      • Golden, Colorado, United States
    • Connecticut
      • New London, Connecticut, United States
    • Florida
      • Fort Lauderdale, Florida, United States
      • Fort Myers, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Winter Haven, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Hawaii
      • Aiea, Hawaii, United States
    • Kansas
      • Wichita, Kansas, United States
    • Maine
      • Portland, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Montana
      • Missoula, Montana, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • New Brunswick, New Jersey, United States
      • Northfield, New Jersey, United States
      • Teaneck, New Jersey, United States
    • New York
      • Lynbrook, New York, United States
      • Orchard Park, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Kingston, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Florence, South Carolina, United States
      • West Columbia, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • 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
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Macular Laser Photocoagulation
Laser therapy
Experimental: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Experimental: 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.
Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Baseline and Week 52
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
Time Frame: Baseline and Week 52
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)
Baseline and Week 52
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
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
Time Frame: Baseline and Week 52
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.
Baseline and Week 52
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
Time Frame: Baseline and Week 52
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.
Baseline and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFT-OD-1009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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