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.
Data availability statement
Data are available on reasonable request.
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Contributors Design: MMB, TAK, SP-J, JBJ. Measurements: MMB, TAK. Statistical analysis: MMB, TAK, SP-J, JBJ. First draft of the manuscript: MMB, TAK, SP-J, JBJ. Revision and final approval of the manuscript: MMB, TAK, SP-J, JBJ.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests JBJ, SP-J: Patent holder with Biocompatibles UK Ltd. (Farnham, Surrey, UK) (Title: Treatment of eye diseases using encapsulated cells encoding and secreting neuroprotective factor and/or anti-angiogenic factor (Patent number: 20120263794); Patent application: European patent application 16 720 043.5 and US patent application US 2019 0085065 A1„ Agents for use in the therapeutic or prophylactic treatment of myopia or hyperopia); Patent application: Agents for the use in the therapeutic or prophylactic treatment of retinal pigment epithelium associated diseases. All other authors: None declared.
Provenance and peer review Not commissioned; externally peer reviewed.