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

Clearside Biomedical, Inc.46 enrolled

Overview

A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).

A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Macular Edema Retinal Vein Occlusion

Interventions

4 mg CLS-TADRUG

40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

ShamDRUG

suprachoroidal sham procedure

IVT afliberceptDRUG

2 mg intravitreal injection of aflibercept

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of macular edema following RVO * History of ME ≤ 12 months * 20-70 letters inclusive BCVA using ETDRS Exclusion Criteria: * has had an IVT injection of anti-VEGF for RVO in the study eye * has had a corticosteroid injection in the past 3 months in the study eye * any uncontrolled ophthalmic condition in the study eye other than RVO

Locations (14)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm

Time frame: 3 months

Data from ClinicalTrials.gov

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