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

Launched by SHANGHAI GENERAL HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Sep 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new gene therapy called LX109, which is being tested to see if it is safe and well-tolerated for patients with a condition known as neovascular age-related macular degeneration (nAMD). nAMD can lead to vision loss due to the growth of abnormal blood vessels in the eye. In this study, participants will receive an injection of LX109 directly into their eye. The trial is not yet recruiting participants, but it aims to enroll adults aged 50 and older who have specific vision problems related to nAMD and have already received treatment for this condition.

To be eligible for this trial, participants must provide consent and have certain eye conditions that meet the study's criteria. For example, they should have active abnormal blood vessels in their eye and a certain level of visual acuity. However, if someone has other serious eye diseases or conditions that could affect their vision or the study's results, they won't be able to participate. If you join the study, you can expect to receive close monitoring and care throughout the trial to ensure your safety and to evaluate how well the treatment works.

Gender

ALL

Eligibility criteria

• 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