Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema

This is a Phase 2, multicenter, randomized, double-masked, controlled, parallel-group study
of 6 months duration in treatment-naïve subjects with DME. This study is projected to enroll
approximately 60 subjects, randomly assigned 1:1 to one of two treatment groups.

The study design includes up to 8 clinic visits over approximately 24 weeks. Subjects will
attend visits for Screening (Visit 1, Days -30 to 0); Randomization and Baseline (Visit 2,
Day 0 before dosing); Dosing and Evaluation (Visit 2 after dosing to Visit 5, Day 0 through
Week 12); As-needed (PRN) Dosing and Follow up (Visit 6 through Visit 7, Week 16 through Week
20), and End of Study (Visit 8, Week 24).

Inclusion Criteria:

- Clinical diagnosis of type 1 or type 2 DM

- DME with central involvement (> 300 µm in the central subfield on spectral-domain
optical coherence tomography [SD-OCT], in the study eye

- ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye

- Naïve to local pharmacologic treatment for DME in the study eye

Exclusion Criteria:

- IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded
if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication

- Any previous treatment in the study eye with an ocular corticosteroid implant

- Has significant media opacity precluding evaluation of retina and vitreous in the
study eye.

- History of glaucoma or optic nerve head change consistent with glaucoma damage

- History of glaucoma surgery

- History of clinically significant IOP elevation in response to corticosteroid
treatment ("steroid responder")