An interventional study of LX109 in To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMD, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
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.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the investigator's judgment, concomitant eye diseases of the study eye at screening or baseline may cause subjects to fail to respond to study therapy or confuse the interpretation of study findings. For example, diabetic retinopathy, retinal vein obstruction, retinal retinal detachment, macular hiatus (stage 3 or 4), uveitis, vitreous macular traction affecting central vision, macular anterior membrane involving macular fovea or damaging macular structure, equivalent spherical lens ≤-8.00D of the study eye, etc.
Eye Treatment： 10. Internal eye surgery, such as vitrectomy, cataract phacoemulsification, trabeculectomy, or other filtering surgery, was performed within 3 months prior to baseline screening or study eye screening; 11. Study eyes screened or treated with intravitreal drug injections or drug-containing intraocular implants other than anti-VEGF drugs, such as intraocular corticosteroids, within 6 months prior to baseline; 12. Research eye or systemic have received gene therapy; 13. Study eyes screened or treated with macular laser photocoagulation or photodynamic therapy (PDT) or full vision membrane laser photocoagulation within 3 months prior to baseline; 14. Study eyes were screened or underwent YAG laser posterior capsulectomy or laser trabeculectomy or laser periiridectomy within 1 month prior to baseline
Drug: LX109
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
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine