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

A Phase III, Multicenter, Randomized, Double-blind, Active Controlled Trial of RC28-E Intravitreal Injection in Subjects With Diabetic Macular Edema

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

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.