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

NCT05885503 | Recruiting Phase 3

• 1 other identifier: 28C005
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change from baseline in BCVA at 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

  Baseline, week 52

Secondary Outcomes (15)

• Average change in BCVA from baseline over the period week 40 through week 52

  Baseline, 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

• Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52

  Baseline, week 52

• Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52

  Baseline, week 52

• Change from baseline in CST at Week 52

  Baseline, week 52

Study Arms (2)

RC-28E

EXPERIMENTAL

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

Aflibercept

ACTIVE COMPARATOR

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

Interventions

RC-28E BIOLOGICAL

Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.

RC-28E

Aflibercept BIOLOGICAL

Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.

Aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Interventions

aflibercept

Study Officials

• Youxin Chen

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghua Xiao

CONTACT

86-010-58076833; xiaosir522@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 2, 2023
• Study Start: June 8, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 5, 2023

Record last verified: 2023-05

Locations

CN (1)