LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Innostellar Biotherapeutics

Status and phase: Enrolling; Phase 1

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Genetic: LX102 subretinal injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06198413

INNOSTELLAR-LX102A01-1

Details and patient eligibility

About

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

Full description

This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.

Enrollment: 12 estimated patients

Sex: All

Ages: 50+ 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
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

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. 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%

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

LX102 Dose 1

Experimental group

Description:

Low dose of LX102

Treatment:

Genetic: LX102 subretinal injection

LX102 Dose 2

Experimental group

Description:

Mid dose of LX102

Treatment:

Genetic: LX102 subretinal injection

LX102 Dose 3

Experimental group

Description:

High dose of LX102

Treatment:

Genetic: LX102 subretinal injection