An Exploratory Clinical Trial Evaluating LX109 Gene Therapy in Patients With nAMD

September 1, 2023 updated by: Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

An Exploratory Clinical Trial Evaluating LX109 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)

To evaluate the safety and tolerability of intravitreal injection of LX109 in patients with nAMD.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, 9 to 12 participants were enrolled in an open monocular, single dose escalation study design. Two dose groups were set up: low dose group (7×109 VG/ eye, 0.05ml) and high dose group (3.5×1010 VG/ eye, 0.05ml). Among them, 3 to 6 subjects were enrolled in low-dose group and 6 subjects were enrolled in high-dose group.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

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) Informed consent must be signed before all assessments; 2) Male or female patients ≥50 years of age; 3) To investigate the presence of active CNV secondary to nAMD (occult or micromenorrhea) in the eye 4) When studying the baseline of the eye, use the ETDRS eye chart to test the BCVA of 19 to 73 letters (approximately equivalent to decimal notation) Recorded visual acuity 0.05-0.5); 5) Study eyes received at least 2 anti-VEGF treatments within 6 months. Note: For all subjects, only one eye was used as the "study eye" (i.e. the study eye receiving treatment). If both eyes of the subject meet the inclusion criteria, the eye with poor baseline vision will be selected as the study eye, or the eye with better vision may be selected for medical reasons or ethical requirements.

Exclusion Criteria:

  • 1. In the investigator's judgment, concomitant eye diseases of the study eye at screening or baseline may cause subjects to fail to respond to study therapy or confuse the interpretation of study findings. For example, diabetic retinopathy, retinal vein obstruction, retinal retinal detachment, macular hiatus (stage 3 or 4), uveitis, vitreous macular traction affecting central vision, macular anterior membrane involving macular fovea or damaging macular structure, equivalent spherical lens ≤-8.00D of the study eye, etc.

    2. To investigate the presence of subretinal hyperreflective substance (SHRM) involving the fovea except CNV lesions; 3. Central serous chorioretinopathy (CSC) was confirmed in the study eyes at any time; 4. Study retinal detachment in the eye at any time; 5. Non-study eye BCV A less than decimal recorded visual acuity 0.05(<19 ETDRS letters); 6. The presence of uncontrolled glaucoma (defined as intraocular pressure ≥25mmHg after standard treatment) in the study eye; 7. Active intraocular or periocular inflammation or infection in the study eye or non-study eye; 8. To investigate the presence of CNV or macular edema secondary to causes other than AMD; 9. In the study, the refractive medium of the eye is seriously cloudy or the pupil cannot be sufficiently dilated, affecting BCVA or causing insufficient acquisition Clear eye imaging data, such as OCT, FFA, and fundus photography, affect researchers' observation of safety and efficacy.

Eye Treatment： 10. Internal eye surgery, such as vitrectomy, cataract phacoemulsification, trabeculectomy, or other filtering surgery, was performed within 3 months prior to baseline screening or study eye screening; 11. Study eyes screened or treated with intravitreal drug injections or drug-containing intraocular implants other than anti-VEGF drugs, such as intraocular corticosteroids, within 6 months prior to baseline; 12. Research eye or systemic have received gene therapy; 13. Study eyes screened or treated with macular laser photocoagulation or photodynamic therapy (PDT) or full vision membrane laser photocoagulation within 3 months prior to baseline; 14. Study eyes were screened or underwent YAG laser posterior capsulectomy or laser trabeculectomy or laser periiridectomy within 1 month prior to baseline

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LX109
Drug: LX109
LX109 gene injection Specification: 0.2ml/bottle, 1.4×1012VG/ml Administration route: intravitreal injection, injection volume 0.05ml/eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Event
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of mean BCVA score on the ETDRS visual acuity scale from baseline.
Time Frame: 4 weeks、24 weeks、52 weeks
Changes of BCVA scores on the ETDRS visual acuity chart of the study eye from baseline at 4, 24 and 52 weeks after treatment with LX109.
4 weeks、24 weeks、52 weeks
Changes in mean eye CST from baseline at 4, 24 and 52 weeks after LX109 treatment were studied.
Time Frame: 4 weeks、24 weeks、52 weeks
4 weeks、24 weeks、52 weeks
The time after LX109 treatment to the first salvage treatment.
Time Frame: 52 weeks
52 weeks
Proportion of subjects receiving salvage treatment in the study eye at 24 weeks and 52 weeks after treatment with LX109.
Time Frame: 24 weeks、52 weeks
24 weeks、52 weeks
The number of times the eye received salvage treatment at 24 weeks and 52 weeks after treatment with LX109 was studied.
Time Frame: 24 weeks、52 weeks
24 weeks、52 weeks

Collaborators and Investigators

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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SHGH-LX109

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.

Clinical Trials on To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMD

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