DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact

NCT00789477 | Completed Phase 2 Results

• 1 other identifier: VGFT-OD-0706
• Study Type: interventional
• Target: 221
• Locations: 3 countries
• Sites: 47

Brief Summary

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)

  Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

  At week 24

Secondary Outcomes (4)

• Change in BCVA From Baseline to Week 52 - LOCF

  At week 52

• Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF

  At week 24 and week 52

• Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF

  At week 24 and week 52

• Number of Focal Laser Treatments

  Week 1 to week 48

Study Arms (5)

Intravitreal Aflibercept Injection .5Q4

EXPERIMENTAL

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks

Drug: Intravitreal Aflibercept Injection

Intravitreal Aflibercept Injection 2Q4

EXPERIMENTAL

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks

Drug: Intravitreal Aflibercept Injection

Intravitreal Aflibercept Injection 2Q8

EXPERIMENTAL

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks

Drug: Intravitreal Aflibercept Injection

Intravitreal Aflibercept Injection 2PRN

EXPERIMENTAL

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria

Drug: Intravitreal Aflibercept Injection

Laser Photocoagulation

ACTIVE COMPARATOR

Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.

Procedure: Laser Photocoagulation

Interventions

Laser Photocoagulation PROCEDURE

laser every 16 weeks as needed

Also known as: macular laser therapy

Laser Photocoagulation

Intravitreal Aflibercept Injection DRUG

Also known as: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye

Intravitreal Aflibercept Injection .5Q4; Intravitreal Aflibercept Injection 2PRN; Intravitreal Aflibercept Injection 2Q4; Intravitreal Aflibercept Injection 2Q8

Eligibility Criteria

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

You may qualify if:

• Patients with clinically significant DME with central involvement
• Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
• ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye

You may not qualify if:

• History of vitreoretinal surgery in the study eye
• Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
• Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening
• Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
• Uncontrolled diabetes mellitus
• Uncontrolled hypertension defined as systolic \> 180mmHg or \> 160 mmHg on 2 consecutive measurements or diastolic \> 100 mmHg on optimal medical regimen
• Ocular disorders in the study eye, other than DME, that may confound interpretation of study results

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Bayer: collaborator

Study Sites (47)

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Artesia, California, 90701, United States

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Beverly Hills, California, 90211, United States

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Mountain View, California, 94040, United States

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Pasadena, California, 91105, United States

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Sacramento, California, 95819, United States

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Santa Ana, California, 92705, United States

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Hamden, Connecticut, 06518, United States

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New London, Connecticut, 06320, United States

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Boynton Beach, Florida, 33426, United States

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Fort Lauderdale, Florida, 33334, United States

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Fort Myers, Florida, 33912, United States

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Ocala, Florida, 34474, United States

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Palm Beach Gardens, Florida, 33410, United States

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Winter Haven, Florida, 33880, United States

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Augusta, Georgia, 30909, United States

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Honolulu, Hawaii, 96815, United States

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Indianapolis, Indiana, 46280, United States

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Bangor, Maine, 04401, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02114, United States

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Jackson, Michigan, 48104, United States

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Kansas City, Missouri, 64108, United States

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Lincoln, Nebraska, 68506, United States

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New Brunswick, New Jersey, 08901, United States

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Northfield, New Jersey, 08225, United States

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Toms River, New Jersey, 08753, United States

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Rochester, New York, 14620, United States

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Charlotte, North Carolina, 28210, United States

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Raleigh, North Carolina, 27607, United States

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Cincinnati, Ohio, 45243, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Greenville, South Carolina, 29605, United States

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West Columbia, South Carolina, 29169, United States

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Nashville, Tennessee, 37203, United States

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Abilene, Texas, 79606, United States

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Arlington, Texas, 76012, United States

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Austin, Texas, 78705, United States

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Houston, Texas, 77030, United States

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McAllen, Texas, 78503, United States

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San Antonio, Texas, 78215, United States

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San Antonio, Texas, 78240, United States

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Salt Lake City, Utah, 84107, United States

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Vienna, 1090, Austria

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Vancouver, British Columbia, V5Z 3N9, Canada

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Victoria, British Columbia, V8V 4X3, Canada

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London, Ontario, N6A 4G5, Canada

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Mississauga, Ontario, L4W 1W9, Canada

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MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron

clinicaltrials@regeneron.com

9148475385

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 11, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2010
• Last Updated: September 9, 2014
• Results First Posted: September 9, 2014

Record last verified: 2014-08

Locations

US (42); AU (1); CA (4)