LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
NCT ID: NCT06198413
Last Updated: 2025-07-01
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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ACTIVE_NOT_RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2023-02-27
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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LX102 Dose 1
Low dose of LX102
LX102 subretinal injection
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
LX102 Dose 2
Mid dose of LX102
LX102 subretinal injection
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
LX102 Dose 3
High dose of LX102
LX102 subretinal injection
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
Interventions
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LX102 subretinal injection
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 50
3. Diagnosis of active CNV secondary to neovascular AMD
4. BCVA ETDRS letters between 5 and 63
5. Subjects must have received a minimum of 2 injections within 6 months prior to screening
6. 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 Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Zhejiang University Eye Hospital
Hangzhou, Zhejiang, China
Shanghai General Hospital
Shanghai, , China
Countries
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Other Identifiers
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INNOSTELLAR-LX102A01-1
Identifier Type: -
Identifier Source: org_study_id
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