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

Completed · Phase 1/Phase 2

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT02949024

Run by

Clearside Biomedical, Inc.

People needed

20

Starts

2016-11-10

Expected to finish

2017-10-17

Last updated by the study team

2021-05-13

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Retina Vitreous Associates Medical Group Inc — Mountain View, California, United States
• Retina Consultants of Houston, PA — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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