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The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC-28E | Experimental | RC-28E 2.0 mg will be initially intravitreal injected (IVT) 5 times at 4 week intervals from week 0 to week 16, then every 8 weeks until week 48. |
|
| Aflibercept | Active Comparator | Aflibercept 2.0mg will be received IVT once every 4 weeks for 5 consecutive times from week 0 to week 16, then once every 8 weeks till week 48. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC-28E | Biological | Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BCVA at Week 52 | BCVA=best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a starting distance of 4 meters | Baseline, week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Average change in BCVA from baseline over the period week 40 through week 52 | For each subject, this endpoint is defined as the average of the changes from baseline to weeks 40, 44, 48 and 52 | Baseline, weeks 40, 44, 48 and 52 |
| Change from baseline in BCVA over time |
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Inclusion Criteria:
Documented diagnosed with type I or type II diabetes mellitus.
Hemoglobin A1c (HBA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1.
Ability and willingness to undertake all scheduled visits and assessments.
The study eye must meet the following requirements:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binghua Xiao | Contact | 86-010-58076833 | xiaosir522@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Youxin Chen | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100010 | China |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Aflibercept | Biological | Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose. |
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BCVA will be assessed at each visit |
| Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52 | Proportion of patients of gaining 4 types of letter counting in BCVA, respectively | Baseline, week 52 |
| Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52 | Proportion of patients of reducing 4 types of letter counting in BCVA, respectively | Baseline, week 52 |
| Change from baseline in CST at Week 52 | CST=central subfield thickness | Baseline, week 52 |
| Mean change from baseline in CST over a period of week 40 through week 52 | CST=central subfield thickness | Baseline, weeks 40, 44, 48 and 52. |
| Change from baseline in CST over time | The change of CST will be assessed from baseline to 52 weeks by every 4 week intervals | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Proportion of patients with absence of intraretinal fluid at Week 52 | Proportion of patients whose intraretinal fluid are completely improved | Baseline, week 52 |
| Proportion of patients with absence of subretinal fluid at Week 52 | Proportion of patients whose subretinal fluid are completely improved | Baseline, week 52 |
| Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52 | Proportion of patients whose intraretinal fluid and subretinal fluid are both completely improved | Baseline, week 52 |
| Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52 | DRSS=Diabetic Retinopathy Severity Scale | Baseline, week 52 |
| Proportion of patients who develop new PDR or high risk PDR at Week 52 | PDR=proliferative diabetic retinopathy | Baseline, week 52 |
| Incidence and severity of ocular adverse events and non-ocular adverse events | during the study | 0~52 weeks |
| Plasma concentration of RC28-E over time | during the study | Baseline, weeks 16, 36 and 48 |
| Presence of ADAs during the study relative to the presence of ADAs at baseline | during the study | Baseline, weeks 12, 24, 36 and 52 |