Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
NCT ID: NCT05885503
Last Updated: 2023-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
316 participants
INTERVENTIONAL
2023-06-08
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
RC-28E
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
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.
Aflibercept
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
Interventions
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RC-28E
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
Aflibercept
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
Eligibility Criteria
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Inclusion Criteria
* 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:
* macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea.
* decreased visual acuity attributable primarily to DME, the best corrected visual acuity (BCVA) 19 or more letters, 78 letters or less.
Exclusion Criteria
* The macular edema of the study eye is mainly caused by other diseases or factors other than DME.
* Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye.
* 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.
* 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.
* Active intraocular or periocular infection or active intraocular inflammation in either eye.
* The study eye with poorly controlled glaucoma.
* A history of idiopathic or autoimmune related uveitis in either eye.
* History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1.
* 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.
* Currently pregnant or breastfeeding, or intend to become pregnant during the study.
* 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.
* 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.
18 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Youxin Chen
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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28C005
Identifier Type: -
Identifier Source: org_study_id
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