Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients

NCT07053358 | Recruiting Early Phase 1

• 1 other identifier: SHGH-LX111
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment

  Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group.

  52 weeks

• Dose Limiting Toxicity

  The incidence of DLT in each dose group.

  4 weeks

Secondary Outcomes (3)

• Mean changes in BCVA from Baseline

  12 weeks, 36 weeks, 52 weeks

• Mean changes in Central Subfield Thickness (CST) from Baseline

  12 weeks, 36 weeks, 52 weeks

• The percentage of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment

  52 weeks

Study Arms (1)

LX111 intravitreal injections

EXPERIMENTAL

Genetic: LX111 Injection

Interventions

LX111 Injection GENETIC

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

LX111 intravitreal injections

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy
• 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.

You may not qualify if:

• 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
• Uncontrolled diabetes defined as HbA1c \>8.0% within 28 days prior to screening

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Innostellar Biotherapeutics Co.,Ltd: collaborator

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200080, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): December 30, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)