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

Neovascular Age-Related Macular Degeneration Clinical Trial

Official title:

A Phase 2, Randomized Controlled, Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196840
• Other study ID #: INNOSTELLAR-LX102A01-2
• Status: Recruiting
• Phase: Phase 2
• Start date: December 21, 2023
• Est. completion date: May 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 overall safety and efficacy of LX102 gene therapy for nAMD.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2029
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

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%.

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

Biological:
• Aflibercept intravitreal injection
Commercially available Active Comparator

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	Mean change from baseline in Best Corrected Visual Acuity (BCVA)	BCVA measured by ETDRS	36 weeks
Secondary	Mean change from baseline in Best Corrected Visual Acuity (BCVA)	BCVA measured by ETDRS	52 weeks
Secondary	Mean change in Central Subfield Thickness (CST) from Baseline	CST measured by spectral domain optical coherence tomography (SD-OCT)	36 weeks, 52 weeks
Secondary	Durability of LX102 treatment	Mean time from LX102 administration to anti-VEGF rescue injection for the first time, percentage of participants requiring anti-VEGF rescue injection, and mean number of anti-VEGF rescue injections through 52 weeks following LX102 administration.	52 weeks
Secondary	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	36 weeks, 52 weeks