Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients

NCT ID: NCT07053358

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-02
• Study Completion Date: 2029-12-30

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LX111 intravitreal injections

Group Type: EXPERIMENTAL

LX111 Injection

Intervention Type: GENETIC

Qualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0.

Interventions

LX111 Injection

Qualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0.

Intervention Type: GENETIC

Eligibility Criteria

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 and demonstrated a meaningful response to anti-VEGF therapy

6. Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.

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 >8.0% within 28 days prior to screening

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innostellar Biotherapeutics Co.,Ltd

INDUSTRY

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xiaodong Sun

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yuanyuan Gong

Role: primary

gyydr@126.com

+86 02136126254

Other Identifiers

SHGH-LX111

Identifier Type: -

Identifier Source: org_study_id