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

Neovascular Age-Related Macular Degeneration Clinical Trial

Official title:

A Dose-Escalation Study of LX102 Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06198413
• Other study ID #: INNOSTELLAR-LX102A01-1
• Status: Recruiting
• Phase: Phase 1
• Start date: February 27, 2023
• Est. completion date: January 2029

Study information

• Verified date: December 2023
• Source: Innostellar Biotherapeutics Co.,Ltd
• Contact: Yang Liu
• Phone: +86-021-50770353
• Email: liuyang[@]innostellarbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 2029
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Genetic:
• LX102 subretinal injection
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap

Locations

Country	Name	City	State
China	Zhejiang University Eye Hospital	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Shanghai General Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innostellar Biotherapeutics Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity (DLT)	Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses	4 weeks
Primary	Incidence of adverse events (AEs) and serious adverse events (SAEs)	Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection	52 weeks
Secondary	Mean change in BCVA from Baseline	BCVA measured by ETDRS	12 weeks, 36 weeks 52 weeks
Secondary	Mean change in Central Subfield Thickness (CST) from Baseline	CST measured by spectral domain optical coherence tomography (SD-OCT)	12 weeks, 36 weeks 52 weeks
Secondary	Mean time from LX102 administration to anti-VEGF rescue injection for the first time		52 weeks
Secondary	Percentage of participants requiring anti-VEGF rescue injection		52 weeks
Secondary	Mean number of anti-VEGF rescue injections		52 weeks