Aim: The aim of the study was to assess the safety and bioactivity of a single intravitreal injection of vascular endothelial growth factor (VEGF) Trap-Eye in subjects with diabetic macular oedema (DMO).
Methods: Five subjects with DMO, foveal thickness ⩾250 μm measured by optical coherence tomography (OCT), and best-corrected visual acuity (BCVA) between 20/40 and 20/320, were enrolled. Each participant received a single intravitreal injection of 4.0 mg of VEGF Trap-Eye followed by a 6-week observation period. Outcome measures included safety and biological activity, including changes in BCVA and excess retinal thickness assessed by OCT.
Results: Injections of VEGF Trap-Eye were well tolerated with no ocular toxicity. One patient had an unrelated serious adverse event: hospitalisation for cellulitis of the left foot 27 days after injection of VEGF Trap-Eye. Median baseline BCVA was 36 ETDRS letters read at 4 m (not ETDRS visual acuity score; Snellen equivalent: 20/50) and median baseline excess central 1 mm foveal thickness (FTH) was 108 μm. At 4 weeks after injection, the median excess FTH was 59 μm and the median improvement in BCVA was nine letters. At 6 weeks after injection, four of the five patients showed improvement in excess FTH (median 74 μm; 31% reduction from baseline, p = 0.0625) and four of the five showed improvement in BCVA (median improvement of three letters).
Conclusions: A single intravitreal injection of 4.0 mg of VEGF Trap-Eye was well tolerated and preliminary evidence of bioactivity was detected. These findings support additional studies investigating multiple injections of VEGF Trap-Eye in patients with DMO.
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Funding: This study was funded by Regeneron Pharmaceuticals, Inc.
Competing interests: D Do, Q Nguyen, S Shah, D Browning and J Haller have no conflicts of interest. P Campochiaro serves on a data and safety monitoring committee for a clinical trial for NVAMD sponsored by Regeneron. K Chu, K Yang, R Vitti and A Ingerman are employees of Regeneron. J M Cedarbaum is a former employee of Regeneron.
Ethics approval: The study was approved by the Western Institutional Review Board.
Patient consent: Obtained.