Purpose: To evaluate the safety and efficacy of treating macular edema, secondary to noninfectious uveitis, with a humanized anti-CD11a antibody.
Methods: Six patients received weekly subcutaneous treatments for 16 weeks according to this open-label, prospective, noncomparative phase I/II trial. Best corrected visual acuity (BCVA) and central macular thickness (CMT) were compared to baseline. Adverse events were recorded and assessed. Blood was sampled to assess the levels of CD56(bright) regulatory NK cells before initiation and after termination of the study.
Results: No serious adverse events were reported by the patients. Patients' ages ranged from 22 to 82 years. Mean BCVA improvements were 6.7 ± 6.9 ETDRS letters in the worse eye and 1.7 ± 5.2 letters in the better eye. Mean CMT reductions were 128 ± 105 μm in the worse eye and 57 ± 68 μm in the better eye. Anti-CD11a antibody treatments resulted in an increase in the CD56(bright) regulatory NK cell population in the peripheral blood of the patients.
Conclusions: Anti-CD11a treatment improved visual function, reduced macular thickness, and increased the level of CD56(bright) regulatory NK cells in patients with uveitic macular edema refractory to other immunosuppressive medications. Targeting CD11a may be beneficial in treating other causes of macular edema.
Trial registration: ClinicalTrials.gov NCT00280826.