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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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