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Table 2 Primary and secondary endpoints and safety endpoints

From: Dexamethasone implants in paediatric patients with noninfectious intermediate or posterior uveitis: first prospective exploratory case series

 

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)

  1. 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