To evaluate the safety and tolerability of intravitreal injection of LX109 in patients with nAMD.
In this study, 9 to 12 participants were enrolled in an open monocular, single dose escalation study design. Two dose groups were set up: low dose group (7×109 VG/ eye, 0.05ml) and high dose group (3.5×1010 VG/ eye, 0.05ml). Among them, 3 to 6 subjects were enrolled in low-dose group and 6 subjects were enrolled in high-dose group.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
LX109 gene injection Specification: 0.2ml/bottle, 1.4×1012VG/ml Administration route: intravitreal injection, injection volume 0.05ml/eye
Adverse Event
Time frame: 4 weeks
Change of mean BCVA score on the ETDRS visual acuity scale from baseline.
Changes of BCVA scores on the ETDRS visual acuity chart of the study eye from baseline at 4, 24 and 52 weeks after treatment with LX109.
Time frame: 4 weeks、24 weeks、52 weeks
Changes in mean eye CST from baseline at 4, 24 and 52 weeks after LX109 treatment were studied.
Time frame: 4 weeks、24 weeks、52 weeks
The time after LX109 treatment to the first salvage treatment.
Time frame: 52 weeks
Proportion of subjects receiving salvage treatment in the study eye at 24 weeks and 52 weeks after treatment with LX109.
Time frame: 24 weeks、52 weeks
The number of times the eye received salvage treatment at 24 weeks and 52 weeks after treatment with LX109 was studied.
Time frame: 24 weeks、52 weeks
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