US-based biopharmaceutical firm Clearside Biomedical has concluded patient enrolment in the exploratory Phase I/II HULK trial of CLS-TA to treat diabetic macular edema (DME).
CLS-TA is a preservative-free formulation of the corticosteroid triamcinolone acetonide.
The open-label, multicentre Phase I/II trial will evaluate the safety and efficacy of CLS-TA administered suprachoroidally in combination with an intravitreal injection of Eylea (aflibercept), a VEGF-inhibitor antibody, in patients who have not received any prior treatment.
The trial will also assess suprachoroidal CLS-TA injection alone in patients who have been previously treated with intravitreal anti-VEGF or intravitreal corticosteroid.
Clearside president and chief executive officer Daniel White said: "We believe that, by administering suprachoroidal CLS-TA with the potential to access the retina and choroid in high amounts concomitantly with intravitreal Eylea, there is the opportunity to more effectively treat DME when compared with current intravitreal anti-VEGF or corticosteroid therapies used alone.
"We are also in the process of final preparations to initiate a larger Phase 2 trial in this blinding eye disease.”
It is expected that the trial's preliminary results will be available in the second half of this year.
Clearside is also planning to commence a larger multi-centre, randomised, masked, controlled Phase II TYBEE clinical trial in the middle of this year to assess suprachoroidal CLS-TA + intravitreal Eylea combination in DME patients over a period of six months compared to intravitreal Eylea alone.
The trial's primary endpoint will be the change in best-corrected visual acuity from baseline.
Image: Diabetic macular edema. Photo: courtesy of National Eye Institute, National Institutes of Health.