Реферат
PURPOSE: To assess the safety of intravitreally applied epidermal growth factor (EGF). METHODS: The clinical interventional, prospective, single-centre, case series study included patients with age-related macular degeneration-related geographic atrophy (GA), in whom the eye with the worse best-corrected visual acuity (BCVA) underwent a single, or repeated, intravitreal injection of EGF (0.75 µg in 50 µL). At baseline and afterwards, the eyes underwent ophthalmological examinations. RESULTS: The study included seven patients (mean age:70.0±12.2 years (range: 54-86 years), with five patients receiving a single injection and two patients receiving two intravitreal injections in an interval of 4 weeks. Mean duration of follow-up was 97±97 days (median:35 days; range: 7-240 days). Mean BCVA was lower at baseline than at study end (1.41±0.44 logMAR vs 0.97±0.12 logMAR; p=0.03). Mean size of the GA lesions did not differ significantly between baseline and study end (29 212±22 887 pixels vs 29 300±22 905 pixels; p=0.59) nor did the mean perimetric mean defect (-10.3±5.9 dB vs 12.0±8.8 dB; p=0.35) or the electroretinographical b-wave amplitude (44.53±31.7 µV vs 64.5±25.5 µV; p=0.12). After a second injection 4 weeks after the first injection, one of two patients developed a cystoid macular oedema in association with an induced incomplete posterior vitreous detachment. It persisted for 3 weeks. Visual acuity in this eye improved from 1.0 logMAR at baseline to 0.80 logMAR at study end. CONCLUSIONS: Except for one eye with temporary, self-resolving cystoid macular oedema, single and repeated intravitreal applications of EGF (0.75 µg) in patients with GA did not lead to intraocular inflammations or any observed intraocular side effect. TRIAL REGISTRATION NUMBER: ISRCTN12733334.