IIIb Trial for RC28-E Injection in Participants With DME and wAMD

November 8, 2026 updated by: RemeGen Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100010
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

DME：

  1. Voluntarily sign the informed consent form and be willing to follow up at the time points specified in the trial;

  2. Aged ≥18 years, male or female;

  3. Diagnosed with Type 1 or Type 2 diabetes mellitus in accordance with diabetes diagnostic criteria;

  4. Glycated hemoglobin (HbA1c) ≤12% within 2 months prior to baseline;

  5. 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:

  1. 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);
  2. 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;
  3. Requiring continuous use of any prohibited medications or treatments (see Section 6.10.1 of this protocol for details);
  4. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RC28-E
Biological: RC28-E

Ophthalmic solution for intravitreal injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence and Severity of Ocular/ Non-ocular Adverse Event.
Time Frame: 52 week
52 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RemeGen Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Youxin Chen, Principal Investigator, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC28-E-C303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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