Visual acuity gains seen in HULK trial
NEW ORLEANS — At 6 months, the HULK phase 1/2 trial demonstrated visual acuity benefit for all patients enrolled and a greater benefit for treatment-naïve eyes, Charles C. Wykoff, MD, said at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting.
The objective of the trial was to evaluate the safety and efficacy of 4 mg Zuprata (triamcinolone acetonide injectable suspension, Clearside Biomedical) administered to the suprachoroidal space alone or in conjunction with 2 mg intravitreal Eylea (aflibercept, Regeneron) for diabetic macular edema.
“A microneedle has been developed specifically for suprachoroidal delivery of preservative-free triamcinolone acetonide, a preparation known as CLS-TA,” Wykoff said. Delivery of corticosteroids into the space maximizes drug levels in the retina while minimizing drug levels in the anterior chamber, potentially reducing cataract acceleration and incidence of IOP, he said.
Twenty patients were enrolled in the open-label, multicenter trial into two arms, treatment naïve and previously treated. Both arms received CLS-TA at baseline, and the treatment-naïve group also received intravitreal aflibercept. Re-treatment was given as needed.
Mean change in visual acuity and central retinal thickness, change in IOP, number of injections given and incidence of adverse events were all study endpoints.
Mean change in visual acuity for all patients was a gain of 5.2 letters.
“These visual acuity gains seemed to be driven by the treatment-naïve arm, which gained 8.5 mean letters at the 6-month endpoint compared to 1.1 mean letters in the previously treated arm,” Wykoff said.
Mean central retinal thickness improved 100 µm to 348 µm in all patients. Mean IOP in all patients was “relatively stable” with a 1 mm Hg to 2.5 mm Hg rise at months 4 and 5, he said. Two patients in the previously treated arm experienced an IOP increase greater than 10 mm Hg.
“A mean of three suprachoroidal CLS-TA injections were given across the 6-month trial, and 50% of patients required zero or one [as-needed] re-treatment,” Wykoff said.
Regarding safety, no serious ocular or systemic events were reported. – by Patricia Nale, ELS
Wykoff CC. Suprachoroidal triamcinolone acetonide with and without intravitreal aflibercept for diabetic macular edema: Phase 1/2 HULK study. Presented at AAO Subspecialty Days; Nov. 10-11, 2017; New Orleans.
Disclosure: Wykoff reports he is a consultant for Clearside Biomedical, which provided funding for the trial.