Print 02 March 2015
Follows the recent initiation of Clearside’s Phase 2 clinical trial for the treatment of macular edema associated with non-infectious uveitis
ALPHARETTA, Ga.- Clearside Biomedical, Inc., a clinical-stage biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye, today announced the enrollment of the first patient in a Phase 2 randomized, controlled, masked, multi-center clinical trial for the treatment of macular edema associated with retinal vein occlusion (RVO) using Clearside’s proprietary formulation of triamcinolone acetonide, CLS-TA, administered via suprachoroidal (SCS) injection using Clearside’s proprietary microinjector.
Seenu Hariprasad, M.D., Professor and Director of Clinical Research and Chief, Vitreoretinal Service at the University of Chicago Department of Ophthalmology and Visual Science, commented, “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.”
Approximately 40 patients will be enrolled at 10 sites in the United States for the Phase 2 clinical trial. All patients will receive one intravitreal injection of Eylea and will be randomized on a 1:1 basis to receive a suprachoroidal injection of either CLS-TA or a sham procedure in the same visit. After randomization, patients will be seen in the clinic once per month for three months.
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. If they do not experience increases in macular edema or reductions in visual acuity at these subsequent visits, they will not receive additional intravitreal Eylea treatments. The primary objective of this study 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.
About Retinal Vein Occlusion
RVO is a sight-threatening disorder resulting from a blockage of one of the veins carrying blood out of the retina. According to a 2010 study published in the journal Ophthalmology, RVO is estimated to affect more than 16 million adults worldwide, and we estimate RVO affects 2.2 million individuals in the United States. In RVO, the blockage of a retinal vein can lead to poor blood circulation, low oxygen and sometimes inflammation. A blocked vein will leak its contents of blood and fluid. Bleeding within the retina and swelling from fluid can create macular edema.
About Clearside Biomedical, Inc.
Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is a clinical-stage biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye. Clearside’s product candidates focus on diseases affecting the retina and the choroid, especially diseases associated with macular edema. Visit www.clearsidebio.com for more information.
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