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Gene Therapy Trial Report

Summary

Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)


NCTID NCT06196840 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term DOID:10871
Compound Name LX102
Sponsor Innostellar Biotherapeutics Co.,Ltd
Funder Type Industry
Recruitment Status
Active not recruiting
Enrollment Count 50 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant VEGF-trap
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Genetic delivery of therapeutic protein
Route of Administration Subretinal
Drug Product Type Viral vector
Delivery System Viral transduction
Vector Type AAV2
Editor Type none
Dose 1 IIT Trial: 3E10 vg/eye or 1E11 vg/eye
Dose 2 2E10 vg
Dose 3 1.25E11 vg

Study Record Dates


Current Stage Phase2
Submit Date 2023-12-25
Completion Date 2029-10
Last Update 2026-03-06

Participation Criteria


Eligible Age 50 Years - 89 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
Inclusion Criteria: 1. Willing to sign the informed consent, and willing to attend follow-up visits. 2. Age ≥ 50, and ≤ 89. 3. Diagnosis of active CNV secondary to neovascular AMD. 4. BCVA ETDRS letters between 19 and 73. 5. Demonstrated a meaningful response to anti-VEGF therapy. Exclusion Criteria: 1. CNV or macular edema in the study eye secondary to diseases other than nAMD. 2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement. 3. Absence of RPE tear at Screening. 4. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months. 5. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg. 6. Uncontrolled diabetes defined as HbA1c \>8.0%.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 11
Locations China

Regulatory Information


Has US IND False
FDA Designations
Recent Updates

Resources/Links