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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Bayer
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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