Comparing RC28-E and Aflibercept for treating diabetic macular edema

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

This study is testing if a new treatment called RC28-E works better than the current option, Aflibercept, for people with diabetic macular edema.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RemeGen Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05885503 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of RC28-E compared to Aflibercept in patients diagnosed with diabetic macular edema. Participants will be monitored for their visual acuity and macular thickening, with assessments scheduled throughout the study. The trial is designed to determine whether RC28-E offers a better treatment option for this condition than the currently used Aflibercept.

Who should consider this trial

Good fit: Ideal candidates include individuals with type I or type II diabetes and specific visual acuity criteria related to diabetic macular edema.

Not a fit: Patients with high-risk proliferative diabetic retinopathy or those whose macular edema is caused by factors other than diabetic macular edema may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from diabetic macular edema.

How similar studies have performed: Other studies have shown success with anti-VEGF treatments for diabetic macular edema, but the specific efficacy of RC28-E compared to Aflibercept is being evaluated for the first time.

Eligibility 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 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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Youxin Chen — Peking Union Medical College Hospital
• Study coordinator: Binghua Xiao

Conditions Diabetic Macular Edema