Table 3.
Main characteristics of studies excluded from the meta-analysis
| Study | Study design | Participants | Intervention | Outcome/results | Evidence strength |
|---|---|---|---|---|---|
| Sen et al38 USA | Phase I, prospective nonrandomized study | Five patients with chronic active anterior uveitis | Single 1,320 μg SCJ sirolimus injection in the study eye Study duration: 4 months |
Primary outcome: Two-step reduction in AC inflammation (according to SUN criteria) within 4 weeks after treatment Results: Three out of five (60%) patients met the primary outcome All patients reported no serious adverse events |
Level 3 |
| Vigil et al39 USA | Prospective, randomized, open-label trial (QoL assessment of the SAVE trial) | 30 patients with noninfectious intermediate uveitis, posterior uveitis, and panuveitis | Two treatment groups Group 1: IVT injections of 352 μg of sirolimus Group 2: SCJ injections of 1,320 μg of sirolimus in the study eye on days 0, 60, and 120 Study duration: 12 months |
Primary outcome: Vision-related QoL measured by the NEI VFQ-39 Results: 26 out of 30 (86.7%) patients completed the VFQ-39 at baseline and at month 6, while 23 out of 30 (76.7%) patients completed up to month 12 Composite scores showed significant improvement in all patients Better tolerability was reported with IVT sirolimus injections |
Level 1+ |
| Shanmuganathan et al40 UK | Prospective, nonrandomized, open-label trial | Eight patients with severe NIU | Systemic sirolimus started at 4 mg daily (increased in 2 mg increments depending on the disease activity and trough blood levels) | Primary outcomes: BCVA gain (>2 lines), control of uveitis activity (inflammatory cell count), CS dose reduction, and symptomatic relief Results: Five out of eight (62.5%) patients responded well to sirolimus treatment Three out of eight (37.5%) had treatment failure in controlling uveitis or had intolerable side effects |
Level 3 |
Abbreviations: BCVA, best-corrected visual acuity; CS, corticosteroid; IVT, intravitreal; NEI-VFQ-39, National Eye Institute 39-Question Visual Function Questionnaire; NIU, noninfectious uveitis; QoL, quality of life; SCJ, subconjunctival; SUN, Standardization of Uveitis Nomenclature; AC, anterior chamber.