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

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ClinicalTrials.gov Identifier: NCT01363440
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : April 20, 2015
Last Update Posted : May 30, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) Procedure: Macular Laser Photocoagulation Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  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) [ 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.


Secondary Outcome Measures :
  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 [ Time Frame: 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 [ Time Frame: 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 [ 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)

  4. 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 ]
  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363440


Locations
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United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
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
United States, Colorado
Colorado Springs, Colorado, United States
Golden, Colorado, United States
United States, Connecticut
New London, Connecticut, United States
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
United States, Georgia
Augusta, Georgia, United States
United States, Hawaii
Aiea, Hawaii, United States
United States, Kansas
Wichita, Kansas, United States
United States, Maine
Portland, Maine, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Montana
Missoula, Montana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
New Brunswick, New Jersey, United States
Northfield, New Jersey, United States
Teaneck, New Jersey, United States
United States, New York
Lynbrook, New York, United States
Orchard Park, New York, United States
Rochester, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Kingston, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Florence, South Carolina, United States
West Columbia, South Carolina, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Tennessee
Nashville, Tennessee, United States
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
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01363440    
Other Study ID Numbers: VGFT-OD-1009
First Posted: June 1, 2011    Key Record Dates
Results First Posted: April 20, 2015
Last Update Posted: May 30, 2016
Last Verified: April 2016
Keywords provided by Regeneron Pharmaceuticals:
Diabetic Macular Edema
Diabetic Retinopathy
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents