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This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with wet age-related macular degeneration by multiple administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC28-E 0.5mg | Experimental | In the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 0.5mg RC28-E every 4 weeks, for 3 consecutive times; In the PRN phase (from week 12 to week 48), the study eye will receive the same dose on an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. |
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| RC28-E 1.0mg | Experimental | In the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 1.0 mg RC28-E every 4 weeks, for 3 consecutive times; In the PRN phase (from week 12 to week 48), the study eye will receive the same dose on an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. |
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| RC28-E 2.0mg | Experimental | In the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 2.0 mg RC28-E every 4 weeks, for 3 consecutive times; In the PRN phase (from week 12 to week 48), the study eye will receive the same dose on an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravitreal injection of RC28-E 0.5mg | Biological | The patient received one treatment of RC28-E 0.5mg in the test group |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change of BCVA from baseline at 12 week; | Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts. | Baseline, Week 12 |
| Mean change of BCVA from baseline at 48 week; | Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts. | Baseline, Week 48 |
| Incidence and severity of AEs | To evaluate the safety of multiple intravitreal injection of RC28-E of each group.) | Baseline up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic (PK) characteristics of RC28-E; | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method. | Baseline up to Week 48 |
| Frequency of administration RC28-E within 48 weeks; |
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Inclusion Criteria:
A patient must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
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| intravitreal injection of RC28-E 1.0mg | Biological | The patient received one treatment of RC28-E 1.0mg in the test group |
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| intravitreal injection of RC28-E2.0mg | Biological | The patient received one treatment of RC28-E 2.0mg in the test group |
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Number of intravitreal injections |
| Baseline up to Week 48 |
| Mean change of BCVA from baseline at Protocol Specified Time-Points. | Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts. | Baseline up to Week 48 |