Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema

RemeGen

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Biological: Aflibercept; Biological: RC-28E

Study type: Interventional

Funder types: Industry

Identifiers

NCT05885503

28C005

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.

Enrollment: 316 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  • 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 study eye with high risk of proliferative diabetic retinopathy.
• 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.
• Other protocol-specified inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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316 participants in 2 patient groups

RC-28E

Experimental group

Description:

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.

Treatment:

Biological: RC-28E

Aflibercept

Active Comparator group

Description:

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.

Treatment:

Biological: Aflibercept