Table 2.
Primary and secondary endpoints and safety endpoints
| Patient 1 | Patient 2 | Patient 3 | |
|---|---|---|---|
| Primary endpoint (month 2) | |||
| VH (reduction) score | 0.5+ | 0.5+ (−1) | 0 (−1.5) |
| Secondary endpoint (month 6) | |||
| BCVA in ETDRS-letters (gain) | 82 (+17) | 79 (+24) | 69 (+11) |
| CRT in μm (reduction) | 265 (−186) | 319 (−1) | 267 (−83) |
| Concomitant medication (change) | CSA 2.1 mg/kg bodyweight daily, (+Decortin 0.1 mg/kg bodyweight once daily) | Decortin 0.2 mg/kg bodyweight once daily | MTX 6.25 mg/m2/once weekly (−MTX 2.5 mg weekly; − Decortin 0.03 mg/kg bodyweight once daily) |
| Safety endpoints (month 6) | |||
| IOP | 19 | 11 | 13 |
| Number of IOP lowering medications during study course (topical or oral) | 3 (topical) | 2 (topical) | 5 (4 topical, 1 oral) |
| Number of IOP lowering surgeries during study course | 0 | 0 | 0 |
| CDR (increase) | 0.2 | 0.2 | 0.2 (+0.1) |
| Cataract status | clear | clear | Subcapsular cataract grade 2+ (no progression) |
VH vitreous haze, BCVA best corrected visual acuity, ETDRS- letters Early Treatment of Diabetic Retinopathy- letters, CRT central retinal thickness, IOP intraocular pressure, CDR cup/ disc- ratio optic nerve head