Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis (PEACHTREE)

Clearside Biomedical

Status and phase

Completed

Phase 3

Conditions

Uveitis, Anterior

Uveitis

Uveitis, Intermediate

Uveitis, Posterior

Panuveitis

Treatments

Drug: Sham Procedure

Drug: 4mg CLS-TA Suprachoriodal Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT02595398

CLS1001-301

Details and patient eligibility

About

The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.

Full description

This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham injection procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.

Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns)
Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters read (20/40 Snellen equivalent), in the study eye

Exclusion criteria

Any active ocular disease or infection in the study eye other than uveitis
Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; subjects are not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.
Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.