Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema

• Status: Completed
• Trial end date: 2017-10-17
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clearside Biomedical, Inc.
• Treatments: Aflibercept; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Men or women ≥ 18 years of age with type 1 or type 2 diabetes mellitus

• DME with central involvement (>320 microns in the central subfield on SD-OCT) in the study eye

• ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye

Exclusion Criteria:

• Evidence of DME due to any other cause other than diabetes mellitus in the study eye

• PRP or focal laser photocoagulation in the study eye within 90 days of screening

• Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye

• History of any previous ophthalmic surgeries in the study eye within 90 days of screening

• High risk PDR in the study eye, for whom enrollment into the study, in the principal investigator's opinion would put the eye at undue risk for vision loss

• Any previous treatment in the study eye with ILUVIEN implant

• Previous treatment for DME in the study eye (TX naive arm only); treatment in the study eye for DME greater than 1 year prior to screening can be considered as treatment naive, at the investigator's discretion

• Subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti-VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only)

• Subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only)