Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged ≥ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.

Eligibility criteria

Qualifiers

Willing to sign the informed consent, and willing to attend follow-up visits.

Age ≥ 50

Diagnosis of active CNV secondary to neovascular AMD

BCVA ETDRS letters between 5 and 63

Disqualifiers

CNV or macular edema in the study eye secondary to diseases other than nAMD

Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement

Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months

Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg

Trial design

Treatments tested in this trial

  • LX111 Injection

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators