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

Completed · Phase 3

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT01363440

Run by

Regeneron Pharmaceuticals

People needed

466

Starts

2011-05-01

Expected to finish

2014-11-01

Last updated by the study team

2016-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Arcadia, California, United States
• Study site — Beverly Hills, California, United States
• Study site — La Jolla, California, United States
• Study site — Mountain View, California, United States
• Study site — Oakland, California, United States
• Study site — Palm Desert, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Torrance, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Golden, Colorado, United States
• Study site — New London, Connecticut, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Winter Haven, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — ‘Aiea, Hawaii, United States
• Study site — Wichita, Kansas, United States
• Study site — Portland, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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