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

Completed · Phase 2

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT00789477

Run by

Regeneron Pharmaceuticals

People needed

221

Starts

2008-12-01

Expected to finish

2010-09-01

Last updated by the study team

2014-09-09

Who can join

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

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

Where it is running

• Study site — Artesia, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Mountain View, California, United States
• Study site — Pasadena, California, United States
• Study site — Sacramento, California, United States
• Study site — Santa Ana, California, United States
• Study site — Hamden, Connecticut, United States
• Study site — New London, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — Winter Haven, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Bangor, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Jackson, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Northfield, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.