Clearside launches phase 2 clinical trial for triamcinolone acetonide

Clearside Biomedical has begun enrollment for a phase 2 clinical trial to evaluate triamcinolone acetonide in the treatment of macular edema associated with retinal vein occlusion, according to a press release.

Clearside’s proprietary formulation of triamcinolone acetonide, CLS-TA, is administered via suprachoroidal injection with the company’s micro-injector.

The multicenter, randomized, controlled trial is designed to gauge the safety and efficacy of a single suprachoroidal injection of CLS-TA combined with a single intravitreal injection of Eylea (aflibercept, Regeneron) vs. an intravitreal injection of Eylea alone.

The study will include about 40 patients enrolled at 10 sites in the U.S. Patients will receive one intravitreal injection of aflibercept and be randomized 1:1 to receive a suprachoroidal injection of CLS-TA or sham treatment during one visit. Subsequently, patients will visit the clinic once a month for 3 months.

Patients in either treatment arm with persistent macular edema or reduced visual acuity will be evaluated at 1, 2 or 3 months after initial treatment to receive additional intravitreal injections of aflibercept.

The study’s main goal is to determine if a single suprachoroidal injection of CLS-TA combined with an intravitreal injection of aflibercept, as opposed to a single intravitreal injection of aflibercept alone, will reduce the need for additional intravitreal aflibercept injections over 3 months.