Fluocinolone Acetonide Insert (ILUVIEN®) for Diabetic Macular Edema (FAD) Study

• Status: Withdrawn
• Trial end date: 2017-08-18
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• To collect post-approval safety data related to intraocular pressure (IOP) after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).

Secondary Objectives:

• To collect visual and anatomic outcome data after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Fluocinolone Acetonide

Criteria

Inclusion Criteria:

• Subjects receiving Iluvien as standard of care for DME

• Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion Criteria:

• None