. 2018 Dec 16;47(1):31–43. doi: 10.1177/0300060518816884

Table 1.

Summary of the most important studies of ILUVIEN®.

Study	Year	Design	Number of patients	Key results
FAME study group^16,20	2011 and 2012	Two parallel, prospective, randomised, sham injection-controlled, double-masked, multicentre clinical trials24- and 36-month follow-ups	Sham, n = 1850.2 µg/day, n = 3750.5 µg/day, n = 393	1. Visual gain of >15 ETDRS letters
				2. BCVA letter score gain at 24 monthsSham: 1.70.2 μg: 4.40.5 μg: 5.43. Glaucoma surgerySham: 0.5%0.2 µg: 3.7%0.5 μg: 7.6 %
ICE-UK³³	2017	Retrospective study involving 13 ophthalmology centresApril 2013–2015, 12-month follow-up	208 patients (233 eyes)	1. Visual gain of >15 ETDRS letters: 18% at 12 months 2. Glaucoma surgery: 0% 3. Glaucoma therapy: 15%
Medisoft Audit Group³⁶	2017	14 clinical centres in the UK, electronic pseudo-anonymised medical record system, retrospective	305 patients (345 eyes)	1. Visual gain of >15 ETDRS letters
				2. Letter gain at 18 and 24 months: 4.5 and 5.33. Requirement for emergent IOP-lowering medication in 22.0% and requirement for glaucoma surgery in 0.8% with a glaucoma diagnosis rate of 2.4%
Pessoa et al.⁴⁰	2018	Retrospective comparative, vitrectomised vs. non-vitrectomised eyes	43 eyes (24 vitrectomised, 19 non-vitrectomised)	1. Visual gain of >15 ETDRS letters 8.5 months
El-Ghrably et al.³⁴	2017	Observational, prospective, multicentre study	57 patients	Gain of 5.1 EDTRS letters at month 12; 22% of patients gained ≥15 EDTRS letters
IRISS⁵²	2018	Prospective, observational, multicentre study	563 patients (593 eyes)	1. 23.3% of patients required IOP-lowering drops 2. 2.3% of patients required glaucoma surgery

ETDRS, Early Treatment Diabetic Retinopathy Study; BCVA, best-corrected visual acuity; IOP, intraocular pressure.