Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Genetic: LX102-C01 Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05831007

SHGH-LX102-C01

Details and patient eligibility

About

The goal of this study is to evaluate the safety and efficacy of LX102-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy.

Enrollment: 6 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

2. Age ≥ 50

3. Diagnosis of active CNV secondary to neovascular AMD

4. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.

5. Subjects must have received a minimum of 2 injections within 6 months prior to screening.

6. Demonstrated a meaningful response to anti-VEGF therapy

Exclusion criteria

1. CNV or macular edema in the study eye secondary to diseases other than nAMD
2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
5. Uncontrolled diabetes defined as HbA1c >7.5%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

LX102-C01 Injection

Experimental group

Description:

Potential doses: 3E10 vg, 0.06 mL/eye/dose 1E11 vg, 0.06 mL/eye/dose

Treatment:

Genetic: LX102-C01 Injection