LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Phase 1

Recruiting

• Conditions: Neovascular Age-Related Macular Degeneration
• Interventions: Genetic: LX102 subretinal injection

• Registration Number: NCT06198413
• Lead Sponsor: Innostellar Biotherapeutics Co.,Ltd

Brief Summary

The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.

Detailed Description

This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.

Study Timeline

• Study Start: 2023-02-27
• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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. BCVA ETDRS letters between 5 and 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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LX102 Dose 2	LX102 subretinal injection	Mid dose of LX102
LX102 Dose 3	LX102 subretinal injection	High dose of LX102
LX102 Dose 1	LX102 subretinal injection	Low dose of LX102

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) and serious adverse events (SAEs)	52 weeks	Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection
Incidence of dose-limiting toxicity (DLT)	4 weeks	Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses

Secondary Outcome Measures

Name	Time	Method
Mean change in Central Subfield Thickness (CST) from Baseline	12 weeks, 36 weeks 52 weeks	CST measured by spectral domain optical coherence tomography (SD-OCT)
Mean time from LX102 administration to anti-VEGF rescue injection for the first time	52 weeks
Percentage of participants requiring anti-VEGF rescue injection	52 weeks
Mean change in BCVA from Baseline	12 weeks, 36 weeks 52 weeks	BCVA measured by ETDRS
Mean number of anti-VEGF rescue injections	52 weeks

Trial Locations

Locations (3)

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

Shanghai General Hospital; 🇨🇳 Shanghai, China

Zhejiang University Eye Hospital; 🇨🇳 Hangzhou, Zhejiang, China