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

• Status: Completed
• Trial end date: 2018-04-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.

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

Details

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

Criteria

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")