LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
A Dose-Escalation Study of LX102 Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
1 other identifier
interventional
12
1 country
3
Brief Summary
The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2023
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2023
CompletedFirst Submitted
Initial submission to the registry
December 25, 2023
CompletedFirst Posted
Study publicly available on registry
January 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
ExpectedJuly 1, 2025
June 1, 2025
1.8 years
December 25, 2023
June 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses
4 weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection
52 weeks
Secondary Outcomes (5)
Mean change in BCVA from Baseline
12 weeks, 36 weeks 52 weeks
Mean change in Central Subfield Thickness (CST) from Baseline
12 weeks, 36 weeks 52 weeks
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 number of anti-VEGF rescue injections
52 weeks
Study Arms (3)
LX102 Dose 1
EXPERIMENTALLow dose of LX102
LX102 Dose 2
EXPERIMENTALMid dose of LX102
LX102 Dose 3
EXPERIMENTALHigh dose of LX102
Interventions
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
Eligibility Criteria
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
- Demonstrated a meaningful response to anti-VEGF therapy
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 \>7.5%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Anhui Provincial Hospital
Hefei, Anhui, China
Zhejiang University Eye Hospital
Hangzhou, Zhejiang, China
Shanghai General Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2023
First Posted
January 10, 2024
Study Start
February 27, 2023
Primary Completion
December 26, 2024
Study Completion (Estimated)
January 1, 2029
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share