Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20213179 | Other Identifier | Center For Drug Evaluation, National Medical Products Administration, China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of JL14002 compared to Lucentis® in subjects with wAMD.
Subjects will be randomised in a 2:1:1 ratio into the JL14002 Experimental Arm, Active Comparator Arm 1, and Active Comparator Arm 2. During the first 12 weeks, all subjects will receive fixed dosing at intervals of every 4 weeks (0.5 mg per dose), with a total of three consecutive doses. Subjects in the JL14002 experimental arm will receive JL14002 monoclonal antibody injection, while those in active comparator arm 1 and active comparator arm 2 will receive ranibizumab injection. Starting from week 12, all subjects will transition to a pro re nata (PRN) dosing regimen. Based on the PRN criteria assessed by the investigator, subjects in the JL14002 experimental arm and active comparator arm 1 will receive JL14002 monoclonal antibody injection as needed, while subjects in active comparator arm 2 will receive ranibizumab injection as needed. All subjects will be required to return to the study site every 4 weeks for safety and efficacy assessments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JL14002 Experimental Arm(Drug: JL14002 monoclonal antibody) | Experimental | For the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg JL14002 once every 4 weeks for a total of 3 consecutive doses. From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen based on pre-specified retreatment criteria. |
|
| Active Comparator Arm 1 (Drug: Ranibizumab→JL14002 monoclonal antibody) | Active Comparator | For the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg Ranibizumab once every 4 weeks for a total of 3 consecutive doses. From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen based on pre-specified retreatment criteria., subjects will receive the JL14002 treatment |
|
| Active Comparator Arm 2 (Drug:Ranibizumab) | Active Comparator | For the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg Ranibizumab once every 4 weeks for a total of 3 consecutive doses. From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen based on pre-specified retreatment criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JL14002 monoclonal antibody(Fixed dosing regimen) | Drug | For the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg JL14002 once every 4 weeks for a total of 3 consecutive doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 | Baseline (Day 0), Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who gained at least 5,10 and 15 letters and lose 15 letters baseline to week 12,week 24 and week 52 | Baseline (Day 0), Week 12, Week 24, Week 52 | |
| Change From Baseline in CRT(central retina thickness) by visit | Baseline (Day 0), Week 12, Week 24, Week 52 |
Not provided
Inclusion Criteria:
1.Ability to understand and voluntarily sign the informed consent form, and willingness to comply with all trial protocol-specified follow-up visits.
2.Aged 50 to 80 years (inclusive), male or female. 3.The study eye must meet all the following criteria:
Exclusion Criteria:
1) Study eye (intraocular/subconjunctival): Intermediate-/short-acting (e.g., triamcinolone) within 90 days; long-acting/sustained-release (e.g., dexamethasone implant) within 180 days.
2) Study eye (periocular): Injection within 28 days before screening; topical ocular use for ≥30 continuous days within 90 days.
3) Systemic: Within 5 days before screening or anticipated need during study (excluding topical, inhaled, intranasal, intra-articular, or short-term oral [<2 weeks] use).
24.Fellow eye BCVA <24 letters (Snellen <20/320) or presence of other potentially blinding conditions.
25.Systemic anti-VEGF therapy within 90 days before the first dose. 26.History of malignancy within 5 years (exceptions: adequately treated basal/squamous cell skin cancer, carcinoma in situ of cervix/breast).
27.Clinically significant abnormal liver or renal function:1) ALT or AST ≥2 × ULN;2) Creatinine or BUN ≥1.5 × ULN 28.Coagulopathy (PT ≥ ULN +3 sec; aPTT ≥ ULN +10 sec). 29.Positive serology for:
30.Pregnancy, lactation, or unwillingness to use highly effective contraception from screening until 180 days after last dose.
31.Participation in another investigational drug/device trial within 90 days before screening (excluding vitamin/mineral studies).
32.Uncontrolled major systemic illness at screening; history of stroke, myocardial infarction, or cerebral infarction within 180 days.
33.Major surgery within 1 month before first dose, or presence of unhealed wounds/ulcers/fractures.
34.Any other condition that, in the investigator's opinion, renders the subject unsuitable for trial participation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ranibizumab(Fixed dosing regimen) | Drug | For the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg Ranibizumab once every 4 weeks for a total of 3 consecutive doses. |
|
|
| JL14002 monoclonal antibody(PRN) | Drug | From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen. Patients will receive 0.5 mg of JL14002 monoclonal antibody injection as needed, based on pre-specified retreatment criteria. |
|
|
| Ranibizumab(PRN) | Drug | From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen. Patients will receive 0.5 mg of Ranibizumab injection as needed, based on pre-specified retreatment criteria. |
|
|
| Change from baseline in CNV area from baseline to week 12 and week 52 | Baseline (Day 0), Week 12, Week 52 |
| BCVA Change From Baseline by visit | Baseline (Day 0), Week 24, Week 52 |
| Incidence of drug-related ocular and systemic adverse reactions at Week 12, Week 24, and Week 52. | Baseline (Day 0), Week 12, Week 24, Week 52 |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided