Clearside Biomedical announces enrollment of first patient in TOPAZ trial
Clearside Biomedical (CLSD) announced the enrollment of the first patient in a Phase 3 clinical trial of suprachoroidal CLS-TA used with an intravitreally administered anti-VEGF agent for the treatment of macular edema associated with Retinal Vein Occlusion.
Suprachoroidal CLS-TA is Clearside’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS, which is the space located between the choroid and the outer protective layer of the eye known as the sclera.
TOPAZ is a multicenter, randomized, masked, controlled trial to assess the safety and efficacy of suprachoroidal CLS-TA used together with one of two intravitreal anti-VEGF agents, Lucentis or Avastin in treatment naive patients with RVO.
Patients in the combination arm of the trial will receive suprachoroidal CLS-TA together with an intravitreal anti-VEGF agent at the beginning of the trial, an intravitreal anti-VEGF agent alone at week 4, and suprachoroidal CLS-TA together with an intravitreal anti-VEGF agent at weeks 12 and 24.
Patients in the control arm will receive an intravitreal anti-VEGF agent alone at the beginning of the trial and every four weeks thereafter through week 24. After 24 weeks, patients in both arms will be followed for approximately an additional six months.
The primary objective of this trial will be to determine the proportion of patients in each arm with a best corrected visual acuity improvement of at least 15 letters from baseline at eight weeks after initial treatment.
Several secondary efficacy and safety endpoints will also be evaluated. Clearside anticipates total enrollment of approximately 460 patients in this Phase 3 trial.
Clearside also announced today that, based on patient enrollment progress, it now expects to report preliminary data from the SAPPHIRE trial in the fourth quarter of 2018 instead of the first quarter of 2019.
CLSD closed at $10.33.
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