An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX102-C01 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

SHGH-LX102-C01

The goal of this study is to evaluate the safety and efficacy of LX102-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy.

2021-12-06

2023-06-01

2024-06-01

Active (not recruiting)

6

Inclusion Criteria: 1. Willing to sign the informed consent, and willing to attend follow-up visits. 1. Age ≥ 50 2. Diagnosis of active CNV secondary to neovascular AMD 3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63. 4. Subjects must have received a minimum of 2 injections within 6 months prior to screening. 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. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months 4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg 5. Uncontrolled diabetes defined as HbA1c \>7.5%

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2023-04-26