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

Not Applicable

Active, not recruiting

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Genetic: LX102-C01 Injection

• Registration Number: NCT05831007
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-06
• Status Verified: 2023-04
• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Last Update Submitted: 2023-04-14
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LX102-C01 Injection	LX102-C01 Injection	Potential doses: 3E10 vg, 0.06 mL/eye/dose 1E11 vg, 0.06 mL/eye/dose

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs)	52 weeks	Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Incidence of adverse events (AEs)	52 weeks	Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses

Secondary Outcome Measures

Name	Time	Method
Mean change in BCVA from Baseline	24 weeks, 52weeks	BCVA measured by ETDRS
Mean number of anti-VEGF injections over time	52 weeks	Mean number of anti-VEGF injections over time
Change of quality of life scores (VFQ-25) from Baseline	52 weeks	Changes of VFQ-25 questionaire from Baseline to 52 weeks
Mean change in Central Subfield Thickness (CST) from Baseline	24 weeks, 52 weeks	To evaluate the effect of LX102-C01 on CST

Trial Locations

Locations (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China