1. Intravitreal panitumumab and myopic macular degeneration.
- Author
-
Bikbov MM, Kazakbaeva GM, Holz FG, Panda-Jonas S, Gilemzianova LI, Khakimov DA, and Jonas JB
- Subjects
- Humans, Female, Male, Aged, Middle Aged, Myopia, Degenerative drug therapy, Myopia, Degenerative physiopathology, Tomography, Optical Coherence, Treatment Outcome, Macular Degeneration drug therapy, ErbB Receptors antagonists & inhibitors, Dose-Response Relationship, Drug, Follow-Up Studies, Panitumumab administration & dosage, Panitumumab therapeutic use, Intravitreal Injections, Visual Acuity physiology
- Abstract
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., Competing Interests: 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., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2024
- Full Text
- View/download PDF