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

This is a Phase 1/2, multicenter, open-label study in subject with DME associated with
diabetes mellitus.

Subjects will be screened and if eligible, will be assigned to study arm at the Baseline
Visit (Visit 1, Day 0).

Following the Baseline Visit, subjects will participate in six month follow-up visits (Visit
2-7; Weeks 4-24) for safety and efficacy assessments and to determine whether additional
therapy is needed based upon established criteria.

Inclusion Criteria:

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

- DME with central involvement 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:

- 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

- 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)