Related Experiment Video
Updated: May 21, 2026
Intravitreal Injections in the Ovine Eye
Published on: July 5, 2022
Intravitreal pegfilgrastim for indirect traumatic optic neuropathy: a first-in-human phase 1/2a study
Chin-Te Huang1,2,3, Yao-Tseng Wen1, Pei-Kang Liu1,4,5
1Institute of Eye Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, 970473, Taiwan.
Background:
Indirect traumatic optic neuropathy (TON) is associated with severe vision loss and no proven treatment.
Aim:
To evaluate the safety and exploratory functional outcomes of intravitreal pegfilgrastim in patients with indirect TON.
Design:
Single-center, open-label, single-arm phase 1/2a proof-of-concept study.
Methods:
Twelve adults with acute unilateral indirect TON received a single intravitreal injection of 0.15 mL pegfilgrastim and were followed for 3 months. Outcomes included adverse events, best-corrected visual acuity (BCVA), visual field mean deviation, retinal nerve fiber layer thickness, and flash visual evoked potentials (VEP).
Results:
No serious ocular or systemic treatment-related adverse events were observed. Transient leukocytosis occurred after treatment and resolved spontaneously. Within-subject improvements in BCVA were observed at 1 week, 1 month, and 3 months (p < 0.05), and visual field mean deviation improved at 3 months (p < 0.05). Retinal nerve fiber layer thickness declined progressively during follow-up. No significant change was detected in VEP latency or amplitude.
Conclusions:
Intravitreal pegfilgrastim was feasible and well tolerated in this first-in-human study of indirect TON. Exploratory functional improvements were observed in a subset of participants, but controlled studies are required to determine whether these changes exceed the natural history of the disease.
