Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)
An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX102-C01 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
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
December 6, 2021
CompletedFirst Submitted
Initial submission to the registry
April 14, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedApril 26, 2023
April 1, 2023
1.5 years
April 14, 2023
April 14, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
52 weeks
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
52 weeks
Secondary Outcomes (4)
Mean change in BCVA from Baseline
24 weeks, 52weeks
Mean change in Central Subfield Thickness (CST) from Baseline
24 weeks, 52 weeks
Mean number of anti-VEGF injections over time
52 weeks
Change of quality of life scores (VFQ-25) from Baseline
52 weeks
Study Arms (1)
LX102-C01 Injection
EXPERIMENTALPotential doses: 3E10 vg, 0.06 mL/eye/dose 1E11 vg, 0.06 mL/eye/dose
Interventions
Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial.
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
- The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 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 (1)
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200080, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- 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
April 14, 2023
First Posted
April 26, 2023
Study Start
December 6, 2021
Primary Completion
June 1, 2023
Study Completion
June 1, 2024
Last Updated
April 26, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share