NCT07362927

Brief Summary

The goal of this study is to evaluate the safety and efficacy of LX111 treatment of DME. This study will enroll participants aged ≥ 18 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for early_phase_1

Timeline
62mo left

Started Mar 2026

Longer than P75 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
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 Progress8%
Mar 2026Sep 2031

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

January 15, 2026

Last Update Submit

March 9, 2026

Conditions

Diabetic Macular Edema (DME)

Outcome Measures

Primary Outcomes (2)

  • Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment

    Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group.

    52 weeks

  • Dose Limiting Toxicity

    The incidence of DLT in each dose group.

    4 weeks

Secondary Outcomes (4)

  • Mean changes in BCVA from Baseline

    12 weeks, 36 weeks, 52 weeks

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

    12 weeks, 36 weeks, 52 weeks

  • The percentage of participants who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment

    52 weeks

  • Proportion of participants achieving an improvement or worsening in DR in the study eye per the ETDRS-DRSS on ultra-wide field fundus photography.

    52 weeks

Study Arms (3)

LX111 Dose Escalation up to 2 dose levels

EXPERIMENTAL

Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.

Genetic: LX111 Injection

LX111 Dose Expansion Dose 1

EXPERIMENTAL

Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.

Genetic: LX111 Injection

LX111 Dose Expansion Dose 2

EXPERIMENTAL

Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.

Genetic: LX111 Injection

Interventions

LX111 InjectionGENETIC

LX111 is an rAAV gene therapy vector carrying a coding sequence for VEGF-trap.

LX111 Dose Escalation up to 2 dose levelsLX111 Dose Expansion Dose 1LX111 Dose Expansion Dose 2

Eligibility Criteria

Age18 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 ≥ 18;
  • Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea;
  • CST ≥ 300 μm in the study eye at Screening;
  • BCVA ETDRS letters between 19 and 73;
  • Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response;
  • Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.

You may not qualify if:

  • Active proliferative diabetic retinopathy (PDR);
  • Presence of iris neovascularization in the study eye at Screening;
  • Retinal laser photocoagulation in the study eye within 3 months prior to Screening;
  • Prior gene therapy in the study eye;
  • The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening.
  • Systemic anti-VEGF treatment within 3 months before Screening;
  • Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to Screening;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai General Hospital

Shanghai, China

RECRUITING

Zhongshan Hospital

Shanghai, China

NOT YET RECRUITING

Central Study Contacts

Li Su

CONTACT

+86 02136126254li.su@shgh.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2031

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)