Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO (SAPPHIRE)

Clearside Biomedical

Status and phase

Terminated

Phase 3

Conditions

Macular Edema

Retinal Vein Occlusion

Treatments

Drug: IVT aflibercept

Drug: suprachoroidal sham

Drug: suprachoroidal CLS-TA

Study type

Interventional

Funder types

Industry

Identifiers

NCT02980874

CLS1003-301

Details and patient eligibility

About

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

Full description

A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion

Enrollment

460 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has a clinical diagnosis of RVO in the study eye
Has a CST of ≥ 300 µm in the study eye
Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye;
Is naïve to local pharmacologic treatment for RVO in the study eye;

Exclusion criteria

Any active ocular disease or infection in the study eye other than RVO
History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication
Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
Any evidence of neovascularization in the study eye