NCT06196840

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
41mo left

Started Jan 2024

Longer than P75 for phase_2

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jan 2024Oct 2029

First Submitted

Initial submission to the registry

December 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

January 24, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2025

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Expected
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

December 25, 2023

Last Update Submit

March 4, 2026

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

Age-related macular degenerationAMDNeovascular AMDNeovascular age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in Best Corrected Visual Acuity (BCVA)

    BCVA measured by ETDRS

    36 weeks

Secondary Outcomes (4)

  • Mean change from baseline in Best Corrected Visual Acuity (BCVA)

    52 weeks

  • Mean change in Central Subfield Thickness (CST) from Baseline

    36 weeks, 52 weeks

  • Durability of LX102 treatment

    52 weeks

  • Incidence of adverse events (AEs) and serious adverse events (SAEs)

    36 weeks, 52 weeks

Study Arms (3)

LX102 Dose 1

EXPERIMENTAL

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

Genetic: LX102 subretinal injection

LX102 Dose 2

EXPERIMENTAL

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

Genetic: LX102 subretinal injection

Control group

ACTIVE COMPARATOR

Aflibercept at a fixed regimen will be administered.

Biological: Aflibercept intravitreal injection

Interventions

LX102 subretinal injectionGENETIC

LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap

LX102 Dose 1LX102 Dose 2
Aflibercept intravitreal injectionBIOLOGICAL

Commercially available Active Comparator

Control group

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to sign the informed consent, and willing to attend follow-up visits.
  • Age ≥ 50, and ≤ 89.
  • Diagnosis of active CNV secondary to neovascular AMD.
  • BCVA ETDRS letters between 19 and 73.
  • Demonstrated a meaningful response to anti-VEGF therapy.

You may not qualify if:

  • CNV or macular edema in the study eye secondary to diseases other than nAMD.
  • Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement.
  • Absence of RPE tear at Screening.
  • Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months.
  • Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg.
  • Uncontrolled diabetes defined as HbA1c \>8.0%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Anhui Provincial Hospital

Hefei, Anhui, China

Location

Zhejiang University Eye Hospital

Hangzhou, Zhejiang, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

Guangzhou Aier Eye Hospital

Guangzhou, China

Location

Zhongshan Ophthalmic Center of Sun Yat-Sen University

Guangzhou, China

Location

Shanghai Eye and ENT Hospital

Shanghai, China

Location

Shanghai General Hospital

Shanghai, China

Location

Shanxi Eye Hospital

Taiyuan, China

Location

Tianjin Medical University Eye Hospital

Tianjin, China

Location

Xuzhou No.1 People's Hospital

Xuzhou, China

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 9, 2024

Study Start

January 24, 2024

Primary Completion

June 24, 2025

Study Completion (Estimated)

October 1, 2029

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(11)