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

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2029-10-31

Brief Summary

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The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.

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Detailed Description

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In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10).

Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.

Conditions

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Neovascular Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LX102 Dose 1

LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0

Group Type EXPERIMENTAL

LX102 subretinal injection

Intervention Type GENETIC

LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap

LX102 Dose 2

LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0

Group Type EXPERIMENTAL

LX102 subretinal injection

Intervention Type GENETIC

LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap

Control group

Aflibercept at a fixed regimen will be administered.

Group Type ACTIVE_COMPARATOR

Aflibercept intravitreal injection

Intervention Type BIOLOGICAL

Commercially available Active Comparator

Interventions

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LX102 subretinal injection

LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap

Intervention Type GENETIC

Aflibercept intravitreal injection

Commercially available Active Comparator

Intervention Type BIOLOGICAL

Eligibility Criteria

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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%.

Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No