Table 4
Treatment-emergent ocular adverse events in the intervention group in 1 year (mITT)
| Participants (n=20) | Number of events | Severity | Outcome | |
|---|---|---|---|---|
| Elevated intraocular pressure | 4 (20%) | 5 | Mild | Recovered or resolved |
| Cataract | 3 (15%) | 4 | Mild | Ongoing in two participants; recovered or resolved in one participant (following extraction) |
| Retinal tear | 2 (10%) | 2 | Mild to moderate | Recovered or resolved (following laserpexy) |
| Eye inflammation | 2 (10%) | 6 | Mild | Recovered or resolved |
| Conjunctival cyst | 1 (5%) | 1 | Mild | Recovered or resolved |
| Conjunctivitis viral | 1 (5%) | 1 | Mild | Recovered or resolved |
| Eye irritation | 1 (5%) | 1 | Moderate | Recovered or resolved |
| Eye pain | 1 (5%) | 1 | Mild | Recovered or resolved |
| Eye pruritus | 1 (5%) | 1 | Moderate | Ongoing |
| Eye swelling | 1 (5%) | 1 | Mild | Recovered or resolved |
| Foreign body sensation in eyes | 1 (5%) | 1 | Mild | Recovered or resolved |
| Iritis | 1 (5%) | 1 | Mild | Recovered or resolved |
| Macular hole/degeneration | 1 (5%) | 2* | Mild to moderate | Recovered or resolved with sequelae; recovered or resolved |
| Maculopathy/epiretinal membrane | 1 (5%) | 2 | Mild | Ongoing |
| Pseudopapilledema† | 1 (5%) | 1 | Mild | Recovered or resolved |
| Retinal hemorrhage | 1 (5%) | 1 | Mild | Recovered or resolved |
One participant in the control group experienced 1 event of photopsia, which was classified as mild and resolved without sequelae. mITT=modified intention to treat.
*In the same eye of a single subject, a full-thickness macular hole spontaneously resolved (with sequelae) to thinning, which subsequently resolved (without sequelae). This was classified as two adverse events, but occurred in the same clinical course of events.
†Disc elevation unrelated to increased intracranial pressure or optic nerve oedema.