Table 6.
Summary of Patients with IOI After Intravitreal Abicipar Injection
| Pt | Age (y)/ Sex/ Study Eye | Classification by Physician | AE Severity | No. of Injections Before AE Onset | Time from Injection to Presentation (Days)a | Duration of AE (Days) | AC Activity | Vitreous Activity | Steroid Treatment Received | Baseline BCVA Letter Score | BCVA at Presen-tation | Final BCVA | Outcome at Study End |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 67/M/OS | Iritis | MILD | 1 | 18 | 14 | +1 cells | None | Topical | 77 | 77 | 25 | Resolved |
| Iritis | MILD | 2 | 6 | 10 | +0.5 cells | None | Topical | 77 | 80 | 25 | Resolved | ||
| 2 | 72/F/OD | Anterior uveitis | MILD | 1 | 19 | 117 | +2 cells; +2 flare | +0.5 cells | Topical | 50 | 50 | 38 | Resolved |
| 3 | 83/M/OD | Vitritis | MILD | 4 | 54 | 36 | +0.5 cells | +2 cells | None reported | 75 | 85 | 81 | Resolved |
| 4b | 74/F/OD | Iritis | MOD | 4 | 29 | 36 | +0.5 cells | +1 cells; +1 debris | Topical | 72 | 77 | 76 | Resolved |
| 5 | 92/M/OD | Anterior uveitis | MOD | 4 | 1 | 29 | +1 cells; +1 flare | None | Topical | 74 | 86 | 83 | Resolved |
| 6 | 60/F/OS | Anterior intermediate uveitis | MOD | 2 | 20 | 234 | +3 cells; +2 flare | +1 haze; +1 cells | Topical + oral | 78 | 64 | 73 | Ongoingc |
| 7 | 88/F/OS | Panuveitis | MOD | 4 | 54 | 18 | +2 cells; +1 flare | None | Topical | 68 | 64 | 74 | Resolved |
| 8 | 60/M/OS | Uveitis | MILD | 1 | 24 | 34 | +2 cells; +1 flare | None | Topical | 75 | 75 | 83 | Resolved |
| Panuveitis | MOD | 3 | 29 | 10 | None | None | Subconjunctival injection | 75 | 83 | 83 | Resolved | ||
| 9 | 79/F/OS | Vitritis, keratic precipitates | MOD | 2 | 26 | 29 | None | +1 haze; +3 cells | Topical | 67 | 66 | 69 | Resolved |
| 10 | 80/F/OS | Iritis | SEV | 4 | 4 | 123 | +1 cells | +2 cells; +2 haze; +2 debris | Topical | 52 | 40 | 55 | Resolved |
| 11d | 79/M/OS | Panuveitis | SEV | 4 | 17 | 132 | +2 cells | Opacities | Topical + oral | 71 | 73 | 62 | Ongoingc |
Notes: aThis number does not necessarily translate to the number of days it took the IOI to resolve as participants were followed up by their study doctor with resolution of IOI noted upon examination. bThis patient was previously treated with 0.5 mg Lucentis from Oct 16, 2017 through Jun 4, 2018 pro re nata. cBoth patients with ongoing IOI were followed for safety reasons after completing the study exit visit and achieved full resolution of IOI within 2 months post exit. dThis patient was previously treated with 0.7 mg Lucentis once on Jun 13, 2018, prior to randomization.
Abbreviations: AE, adverse event; AC, anterior chamber; BCVA, best-corrected visual acuity; F, female; IOI, intraocular inflammation; M, male; MOD, moderate; OD, right eye; OS, left eye; Pt, patient; SEV, severe.