Neovascular Age-related Macular Degeneration
Conditions
Brief summary
The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged ≥ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.
Interventions
GENETICLX111 Injection
Qualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Innostellar Biotherapeutics Co.,Ltd
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. 2. Age ≥ 50 3. Diagnosis of active CNV secondary to neovascular AMD 4. BCVA ETDRS letters between 5 and 63 5. Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy 6. 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.
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 \>8.0% within 28 days prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment | 52 weeks | Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group. |
| Dose Limiting Toxicity | 4 weeks | The incidence of DLT in each dose group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean changes in BCVA from Baseline | 12 weeks, 36 weeks, 52 weeks | The mean changes of BCVA scores on the ETDRS chart at different timepoints after LX111 treatment compared with baseline. |
| Mean changes in Central Subfield Thickness (CST) from Baseline | 12 weeks, 36 weeks, 52 weeks | The mean changes of CST at different timepoints after LX111 treatment compared with baseline. |
| The percentage of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment | 52 weeks | The proportion of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment |
Countries
China
Outcome results
None listed