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

December 25, 2023 updated by: Innostellar Biotherapeutics Co.,Ltd

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai General Hospital
        • Principal Investigator:
          • Hong Wang
        • Contact:
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Kai Dong
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang University Eye Hospital
        • Contact:
        • Principal Investigator:
          • Ke Yao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LX102 Dose 1
LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0
Genetic: LX102 subretinal injection
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
Experimental: LX102 Dose 2
LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0
Genetic: LX102 subretinal injection
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
Active Comparator: Control group
Aflibercept at a fixed regimen will be administered.
Biological: Aflibercept intravitreal injection
Commercially available Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Time Frame: 36 weeks
BCVA measured by ETDRS
36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Time Frame: 52 weeks
BCVA measured by ETDRS
52 weeks
Mean change in Central Subfield Thickness (CST) from Baseline
Time Frame: 36 weeks, 52 weeks
CST measured by spectral domain optical coherence tomography (SD-OCT)
36 weeks, 52 weeks
Durability of LX102 treatment
Time Frame: 52 weeks
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
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 36 weeks, 52 weeks
Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection
36 weeks, 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innostellar Biotherapeutics Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

December 25, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 25, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INNOSTELLAR-LX102A01-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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