Back to resultsSafety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)
Primary Purpose
Neovascular Age-related Macular Degeneration
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LX102-C01 Injection
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration
Eligibility Criteria
Inclusion Criteria: 1. 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 Exclusion Criteria: 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%
Sites / Locations
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LX102-C01 Injection
Arm Description
Potential doses: 3E10 vg, 0.06 mL/eye/dose 1E11 vg, 0.06 mL/eye/dose
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Secondary Outcome Measures
Mean change in BCVA from Baseline
BCVA measured by ETDRS
Mean change in Central Subfield Thickness (CST) from Baseline
To evaluate the effect of LX102-C01 on CST
Mean number of anti-VEGF injections over time
Mean number of anti-VEGF injections over time
Change of quality of life scores (VFQ-25) from Baseline
Changes of VFQ-25 questionaire from Baseline to 52 weeks
Full Information
NCT ID
NCT05831007
First Posted
April 14, 2023
Last Updated
April 14, 2023
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Innostellar Biotherapeutics
1. Study Identification
Unique Protocol Identification Number
NCT05831007
Brief Title
Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Innostellar Biotherapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LX102-C01 Injection
Arm Type
Experimental
Arm Description
Potential doses:
3E10 vg, 0.06 mL/eye/dose
1E11 vg, 0.06 mL/eye/dose
Intervention Type
Genetic
Intervention Name(s)
LX102-C01 Injection
Intervention Description
Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial.
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Time Frame
52 weeks
Title
Incidence of serious adverse events (SAEs)
Description
Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Mean change in BCVA from Baseline
Description
BCVA measured by ETDRS
Time Frame
24 weeks, 52weeks
Title
Mean change in Central Subfield Thickness (CST) from Baseline
Description
To evaluate the effect of LX102-C01 on CST
Time Frame
24 weeks, 52 weeks
Title
Mean number of anti-VEGF injections over time
Description
Mean number of anti-VEGF injections over time
Time Frame
52 weeks
Title
Change of quality of life scores (VFQ-25) from Baseline
Description
Changes of VFQ-25 questionaire from Baseline to 52 weeks
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 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
Exclusion Criteria:
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%
Facility Information:
Facility Name
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200080
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)
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