Clearside Biomedical Announces Completion of Patient Enrollment in Phase 2 Clinical Trial of CLS-TA Used Together with Eylea in Patients with Diabetic Macular Edema
24 October 2017
DME is the most common cause of vision loss in people with diabetes mellitus. A consequence of diabetic retinopathy, DME is swelling in the area of the retina called the macula caused by leaking blood vessels. DME affects up to 30% of people who have had diabetes for 20 years or more, and if untreated, approximately 20 to 30% of people who have it will experience moderate visual loss.
The TYBEE trial, a multicenter, randomized, masked, controlled Phase 2 trial, has enrolled 71 patients who are naïve to pharmacologic treatment for DME. In this trial, patients were randomized into either a combination arm to receive suprachoroidal CLS-TA together with intravitreal Eylea or a control arm to receive only intravitreal Eylea. The primary outcome measure is a comparison of mean change from baseline in best corrected visual acuity between the two study arms. An additional analysis will be a comparison between the number of injections required between the two groups.
“The completion of patient enrollment in the TYBEE trial represents an important milestone and step forward in our DME clinical development program. We have eclipsed over 300 patients who have been treated for sight threatening diseases with suprachoroidal CLS-TA,” said
CLS-TA for suprachoroidal administration, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline for the treatments of unmet or underserved blinding eye diseases where the pathologies manifest in the choroid and retina.
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