Background In experimental studies, intravitreally applied antibodies against epidermal growth factor (EGF), EGF family members (amphiregulin, neuregulin-1, betacellulin, epigen, epiregulin) and against the EGF receptor (EGFR) were associated with a reduction in lens-induced axial elongation and decrease in physiological eye elongation in guinea pigs and in non-human primates. Here, we investigated the intraocular tolerability and safety of a fully human monoclonal IgG2-antibody against EGFR, already in clinical use in oncology, as a potential future therapeutic approach for axial elongation in adult eyes with pathological myopia.
Methods The clinical, monocentre, open-label, multiple-dose, phase-1 study included patients with myopic macular degeneration of stage 4, who received intravitreal injections of panitumumab in various doses and in intervals ranging between 2.1 months and 6.3 months.
Results The study included 11 patients (age:66.8±6.3 years), receiving panitumumab injections in doses of 0.6 mg (4 eyes; 1×1 injection, 3×2 injections), 1.2 mg (4 eyes; 1×1 injection, 2×2 injections, 1×3 injections) and 1.8 mg (3 eyes; 1×1 injection, 2×2 injections), respectively. None of the participants showed treatment-emergent systemic adverse events or intraocular inflammatory reactions. Best-corrected visual acuity (1.62±0.47 logarithm of the minimal angle of resolution (logMAR) vs 1.28±0.59 logMAR; p=0.08) and intraocular pressure (13.8±2.4 mm Hg vs 14.3±2.6 mm Hg; p=0.20) remained unchanged. In nine patients with a follow-up of >3 months (mean:6.7±2.7 months), axial length did not change significantly (30.73±1.03 mm vs 30.77±1.19 mm; p=0.56).
Conclusions In this open-labelled, phase-1 study with a mean follow-up of 6.7 months, panitumumab repeatedly administered intravitreally up to a dose of 1.8 mg was not associated with intraocular or systemic adverse effects. During the study period, axial length remained unchanged.
Trial registration number DRKS00027302.
- optics and refraction
Data availability statement
Data are available on reasonable request.
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Contributors Design of the study: MMB, GMK, FGH and JBJ; Funding: MMB; Examination of study participants and clinical images: MMB, GMK, SP-J, LIG, DAK and JBJ; Supervision: MMB, GMK; Writing the first manuscript draft: SP-J and JBJ; Revision and final approval of the manuscript: MMB, GMK, FGH, SP-J, LIG, DAK and JBJ. Guarantors are MMB and 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 and SP-J: Patent holder with Biocompatibles UK (Franham, Surrey, UK) (Jonas JB, Wallrapp C, Geigle P, Panda-Jonas S, Thoemes E): (Title: Treatment of eye diseases using encapsulated cells encoding and secreting neuroprotective factor and / or anti-angiogenic factor; Patent number: 20120263794), and European patent EP 3 271 392, JP 2021-119187, and US 2021 0340237 A1: Agents for use in the therapeutic or prophylactic treatment of myopia or hyperopia; Patent application: European patent application: WO 2021/198369 A1; PCT/EP2021/058500: Agents for the use in the therapeutic or prophylactic treatment of retinal pigment epithelium associated diseases.
Provenance and peer review Not commissioned; externally peer reviewed.