Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RC-28E 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. |
Biological: RC-28E
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
|
| Active Comparator: Aflibercept 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. |
Biological: Aflibercept
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in BCVA at Week 52 [Baseline, 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
Secondary Outcome Measures
- Average change in BCVA from baseline over the period week 40 through week 52 [Baseline, weeks 40, 44, 48 and 52]
For each subject, this endpoint is defined as the average of the changes from baseline to weeks 40, 44, 48 and 52
- Change from baseline in BCVA over time [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]
BCVA will be assessed at each visit
- Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52 [Baseline, week 52]
Proportion of patients of gaining 4 types of letter counting in BCVA, respectively
- Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52 [Baseline, week 52]
Proportion of patients of reducing 4 types of letter counting in BCVA, respectively
- Change from baseline in CST at Week 52 [Baseline, week 52]
CST=central subfield thickness
- Mean change from baseline in CST over a period of week 40 through week 52 [Baseline, weeks 40, 44, 48 and 52.]
CST=central subfield thickness
- Change from baseline in CST over time [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]
The change of CST will be assessed from baseline to 52 weeks by every 4 week intervals
- Proportion of patients with absence of intraretinal fluid at Week 52 [Baseline, week 52]
Proportion of patients whose intraretinal fluid are completely improved
- Proportion of patients with absence of subretinal fluid at Week 52 [Baseline, week 52]
Proportion of patients whose subretinal fluid are completely improved
- Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52 [Baseline, week 52]
Proportion of patients whose intraretinal fluid and subretinal fluid are both completely improved
- Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52 [Baseline, week 52]
DRSS=Diabetic Retinopathy Severity Scale
- Proportion of patients who develop new PDR or high risk PDR at Week 52 [Baseline, week 52]
PDR=proliferative diabetic retinopathy
- Incidence and severity of ocular adverse events and non-ocular adverse events [0~52 weeks]
during the study
- Plasma concentration of RC28-E over time [Baseline, weeks 16, 36 and 48]
during the study
- Presence of ADAs during the study relative to the presence of ADAs at baseline [Baseline, weeks 12, 24, 36 and 52]
during the study
Eligibility Criteria
Criteria
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
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Ability and willingness to undertake all scheduled visits and assessments.
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The study eye must meet the following requirements:
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macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea.
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decreased visual acuity attributable primarily to DME, the best corrected visual acuity (BCVA) 19 or more letters, 78 letters or less.
Exclusion Criteria:
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The study eye with high risk of proliferative diabetic retinopathy.
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The macular edema of the study eye is mainly caused by other diseases or factors other than DME.
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Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye.
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Administration of IVT any other anti-VEGF drugs in the study eye within 3 months and/or in the other eye within 7 days prior to Day 1.
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Any intraocular long-acting or sustained release corticosteroid treatment (e.g., dexamethasone intravitreal implant) in the study eye within 6 months prior to Day 1.
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Active intraocular or periocular infection or active intraocular inflammation in either eye.
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The study eye with poorly controlled glaucoma.
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A history of idiopathic or autoimmune related uveitis in either eye.
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History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1.
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Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest.
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Currently pregnant or breastfeeding, or intend to become pregnant during the study.
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Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye.
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Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye.
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Other protocol-specified inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- RemeGen Co., Ltd.
Investigators
- Principal Investigator: Youxin Chen, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 28C005