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

Innostellar Biotherapeutics

Status and phase: Enrolling; Phase 2

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Biological: Aflibercept intravitreal injection; Genetic: LX102 subretinal injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06196840

INNOSTELLAR-LX102A01-2

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

LX102 Dose 1

Experimental group

Description:

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

Treatment:

Genetic: LX102 subretinal injection

LX102 Dose 2

Experimental group

Description:

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

Treatment:

Genetic: LX102 subretinal injection

Control group

Active Comparator group

Description:

Aflibercept at a fixed regimen will be administered.

Treatment:

Biological: Aflibercept intravitreal injection