Neovascular Age-related Macular Degeneration
Conditions
Brief summary
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.
Interventions
GENETICLX102-C01 Injection
Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial.
Sponsors
Innostellar Biotherapeutics
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | 52 weeks | Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses |
| Incidence of serious adverse events (SAEs) | 52 weeks | Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in BCVA from Baseline | 24 weeks, 52weeks | BCVA measured by ETDRS |
| Mean change in Central Subfield Thickness (CST) from Baseline | 24 weeks, 52 weeks | To evaluate the effect of LX102-C01 on CST |
| Mean number of anti-VEGF injections over time | 52 weeks | Mean number of anti-VEGF injections over time |
| Change of quality of life scores (VFQ-25) from Baseline | 52 weeks | Changes of VFQ-25 questionaire from Baseline to 52 weeks |
Countries
China
Outcome results
None listed