Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)
NCT ID: NCT05831007
Last Updated: 2023-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6 participants
INTERVENTIONAL
2021-12-06
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LX102-C01 Injection
Potential doses:
3E10 vg, 0.06 mL/eye/dose
1E11 vg, 0.06 mL/eye/dose
LX102-C01 Injection
Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial.
Interventions
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LX102-C01 Injection
Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial.
Eligibility Criteria
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Inclusion Criteria
1. Age ≥ 50
2. Diagnosis of active CNV secondary to neovascular AMD
3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.
4. Subjects must have received a minimum of 2 injections within 6 months prior to screening.
5. Demonstrated a meaningful response to anti-VEGF therapy
Exclusion Criteria
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 \>7.5%
50 Years
ALL
No
Sponsors
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Innostellar Biotherapeutics
UNKNOWN
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Xiaodong Sun
PhD
Locations
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Other Identifiers
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SHGH-LX102-C01
Identifier Type: -
Identifier Source: org_study_id
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