IIIb Trial for RC28-E Injection in Participants With DME and wAMD
An Open-Label, Multicenter, Single-Arm Phase IIIb Clinical Trial to Evaluate the Safety and Tolerability of RC28-E Injection in Participants With Diabetic Macular Edema and Wet Age-Related Macular Degeneration
The purpose of this study is to primarily determine the safety profile of RC28-E in participants with DME and wAMD. Also explore the efficacy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Binghua Xiao
- Phone Number: 86-010-58076833
- Email: xiaosir522@163.com
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100010
- Peking Union Medical College Hospital
-
Contact:
- Youxin Chen, M.D.
- Phone Number: 13801025972
- Email: chenyouxinpumch@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
DME：
-
Voluntarily sign the informed consent form and be willing to follow up at the time points specified in the trial;
-
Aged ≥18 years, male or female;
-
Diagnosed with Type 1 or Type 2 diabetes mellitus in accordance with diabetes diagnostic criteria;
-
Glycated hemoglobin (HbA1c) ≤12% within 2 months prior to baseline;
-
The study eye must meet all of the following requirements:
- Diabetic macular edema involving the fovea centralis (the region with a diameter of 1 mm centered at the macular fovea), resulting in decreased visual acuity of the trial participant;
- Best Corrected Visual Acuity (BCVA) ≥19 letters and ≤78 letters (using ETDRS chart);
- Central Subfield Thickness (CST) on OCT ≥300 μm; The clarity of refractive media and pupillary condition of the study eye shall allow high-quality fundus imaging and shall not affect disease assessment.
wAMD：
-
Voluntarily sign the informed consent form and be willing to undergo follow-up at the time points specified in the trial;
(2) Aged ≥50 years at baseline, male or female;
(3) Confirmed diagnosis of wet age-related macular degeneration (wAMD);
(4) Any type of active macular neovascularization (MNV) secondary to wAMD (including predominantly classic, minimally classic or occult choroidal neovascularization (CNV), polypoidal choroidal vasculopathy (PCV) as a subtype, retinal angiomatous proliferation (RAP) as a special type. Active MNV is defined as the presence of intraretinal or subretinal fluid, subretinal hyperreflective material on OCT, fluorescein leakage on FFA, or evidence of recent hemorrhage), meeting all of the following characteristics:
-
CNV or lesions caused by CNV involve the central macular region (e.g., macular edema, subretinal, sub-RPE or intraretinal fluid, retinal pigment epithelial detachment (PED), subretinal or sub-RPE hemorrhage, blocked fluorescence, etc. The reading area for the central macular region is a 1 mm diameter area centered at the fovea);
-
Total lesion area ≤12 disc areas on FFA (total lesion area includes hemorrhage, atrophy, fibrosis and neovascularization);
-
Evidence of CNV leakage confirmed on FFA;
-
Intraretinal fluid or subretinal fluid demonstrated on OCT;
(5) Best Corrected Visual Acuity (BCVA) of the study eye ≥19 letters and ≤78 letters (using ETDRS chart);
(6) The clarity of refractive media and pupillary condition of the study eye shall allow high-quality fundus imaging and shall not affect disease assessment.
*If both eyes satisfy the inclusion criteria, the eye with worse BCVA shall be the study eye, unless the investigator deems the other eye more appropriate.
-
Exclusion Criteria:
- Subjects with other diseases, metabolic disorders, or abnormal clinical laboratory findings where there is a reasonable suspicion that such disease or condition contraindicates RC28-E Injection, may interfere with the interpretation of study results, or places the trial participant at a high risk of treatment complications (including but not limited to: coagulation disorders; history of acute cardiovascular and cerebrovascular events within 180 days prior to screening, including but not limited to cerebrovascular accident and acute myocardial infarction; history of treated or untreated malignant neoplasm within the past 5 years, except for cutaneous squamous cell carcinoma and basal cell carcinoma with complete resection and no evidence of metastasis, local carcinoma in situ of the cervix, carcinoma in situ of the prostate, or papillary thyroid carcinoma; severe arrhythmia requiring pharmacotherapy, severe hepatic or renal disease, severe decompensated heart failure, or New York Heart Association (NYHA) Class III or IV heart failure);
- History of severe hypersensitivity or anaphylactic reaction to biological agents, or known hypersensitivity to any component of RC28-E Injection, study-related procedural agents (including fluorescein sodium), mydriatic eye drops, or any anesthetic and antimicrobial agents to be used by trial participants in this study;
- Requiring continuous use of any prohibited medications or treatments (see Section 6.10.1 of this protocol for details);
- Trial participants with prior exposure to RC28-E Injection;
Other ocular or systemic conditions that, in the investigator's opinion, render the subject unsuitable for enrollment in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RC28-E
|
Ophthalmic solution for intravitreal injection |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence and Severity of Ocular/ Non-ocular Adverse Event.
Time Frame: 52 week
|
52 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Youxin Chen, Principal Investigator, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC28-E-C303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.