HULK trial outlined
HULK trial was an investigator-initiated multicenter trial that enrolled a total of 20 patients, of which 50% were treatment naïve and the other 50% had been previously treated. All treatment-naïve patients received intravitreal aflibercept 2 mg (Eylea, Regeneron) at baseline in addition to CLS-TA. The previously treated group had received an average of 23 prior treatments, which were comprised primarily of intravitreal injections with an anti-VEGF agent or corticosteroid, and received CLS-TA only.
Beginning at 2 months, all patients were eligible to receive suprachoroidal CLS-TA injection as needed (prn) if central retinal thickness (CRT) was >320 µm and not improved by at least 20% from the prior 2 visits.
At baseline, mean best corrected visual acuity (BCVA) was about 20/50 in both the treatment-naïve and previously treated arms. Mean CRT in the previously treated group was thicker than in the treatment-naïve eyes, 483 µm versus 442 µm.
The study had good retention and compliance. A single patient withdrew at month 4 and overall, less than 4% of scheduled visits were missed.
The eligibility criteria for retreatment were met for 53% of the 74 possible prn retreatments. In the previously treated and treatment-naive arms, retreatment was delivered for 61% and 44% of possible retreatments, respectively. Mean number of CLS-TA injections given over the 6-month trial was 3, and 50% of patients required either no or just 1 retreatment.