US-based biopharmaceutical firm Clearside Biomedical has started patient enrolment in a Phase II trial of its proprietary formulation of triamcinolone acetonide, CLS-TA, to treat macular edema associated with retinal vein occlusion (RVO).
In this clinical trial, CLS-TA will be administered through suprachoroidal (SCS) injection using the company’s microinjector.
The randomised, controlled, masked, multi-centre Phase II trial will enrol around 40 patients at ten sites in the US.
During the trial, all patients will receive one intravitreal injection of Eylea and will be randomised on a 1:1 basis to receive a suprachoroidal injection of either CLS-TA or a sham procedure in the same visit.
The company said that following randomisation, patients will be seen in the clinic once per month for three months.
University of Chicago Department of Ophthalmology and Visual Science professor and director of Clinical Research and chief of Vitreoretinal Service Seenu Hariprasad said: "Generally, patients suffering from macular edema associated with RVO require treatment every month.
"This is a burden on the patient, caregiver and physician. The trial is designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA together with an intravitreal injection of Eylea, compared to an intravitreal injection of Eylea alone.
"We are seeking to determine if concomitant use of CLS-TA and Eylea can extend the treatment interval for additional intravitreal Eylea injections to at least three months."
According to the company, patients in either treatment arm will be evaluated at the subsequent visits one-, two- and three-months after the initial assigned treatment to receive additional intravitreal injections of Eylea, if they continue to experience macular edema or reductions in visual acuity.
Patients will not receive additional intravitreal Eylea treatments, if they do not experience increases in macular edema or reductions in visual acuity at these subsequent visits.
The trial’s primary objective is to determine if a single suprachoroidal injection of CLS-TA administered along with an intravitreal injection of Eylea, compared to a single intravitreal injection of Eylea alone, will decrease the need for additional intravitreal Eylea treatments over three months.