Ocular findings and treatment-emergent ocular adverse events
vitritis, retinal flame hemorrhage, itching, abnormal visual fields, Retinal vascular AEs, Ocular adverse, opacity, ocular adverse, cataract, optic nerve retinal nerve fiber layer, floaters, cataracts
VITRITIS, CATARACTS, RETINAL VASCULAR DISORDER, SCAR, ANTERIOR UVEITIS, OPACITY, CORNEA, CATARACT, RETINAL FLAME HEMORRHAGE, CATARACT IN THE RIGHT EYE
Only six of 154 study participants had MfAC detected at any time during the study (Part 2). These included participants with MfAC at baseline only with total MfAC counts from both eyes of 1, 1, and 8, one with MfAC at baseline and at 3 months after treatment (total MfAC was 1 at both time points), one with MfAC (1 Mf seen) on day 7 after treatment, and one with MfAC (1 Mf) only at 3 months after treatment. Ocular adverse events were documented in 16 participants within three months after treatment, and these were equally distributed across the three treatment groups (see All ocular adverse events were of mild or moderate severity. No participant with MfAC observed at any time during the Part 2 study experienced an ocular AE. Intraocular AEs included vitritis, worsening cataract, retinal vascular disorders, and punctate corneal opacity. Three participants developed mild vitritis that did not affect visual acuity and spontaneously resolved later in the study. These participants did not report floaters, and they did not have anterior uveitis. Retinal vascular AEs (2) included a cotton wool spot with onset 3 months after treatment in one participant and a retinal flame hemorrhage in one participant that was first noticed on day 3 after treatment and resolved spontaneously. Two participants had reduced pinhole visual acuity after treatment compared to baseline. One had itching and mild worsening of a baseline cataract in the right eye, and the other had worsening of cataracts in both eyes. Sixteen of 21 (76.2%) of all ocular AEs had resolved by the 3 month follow-up examination. Persistent AEs included mild worsening cataracts (2 subjects in the IA arm, 1 subject in the IDA3 arm), punctate opacity in the cornea that was believed to be related to a small scar related to particulate (sand) injury (1 subject in the IDA3 arm), and the cotton wool spot which was first seen at 3 months and resolved later (1 subject in the IDA3 arm). None of the late AEs were associated with reduced visual acuity.Optical coherence tomography imaging was performed prior to treatment and on day 3, day 7 and month 3 after treatment. Two parameters commonly assessed by OCT are central subfield thickness of the macula (CST) and optic nerve retinal nerve fiber layer (RNFL) thickness. No changes in CST or RNFL were observed after treatment. 144 participants had no change in visual field interpretation at any time during the study. Also, no participant with a normal baseline FDT (visual field) test had an abnormal result at the time of their final FTD test. Four participants with normal baseline FDT examinations had abnormal results on day 3 or 7 after treatment. However, FDT scores were normal in all of these participants by 3 months after treatment. Six participants with abnormal visual fields at baseline had normal visual field results during subsequent visits. Thus, the few differences noted in FDT results during this study were likely due to day to day variability in the assessment, and we do not consider them to represent ocular adverse events related to treatment.