- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04782128
Evaluation of RC28-E Injection in Diabetic Retinopathy
October 10, 2023 updated by: RemeGen Co., Ltd.
A Randomized, Open-label, Multicenter Study of the Efficacy and Safety of RC28-E Injection in Subjects With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Beijing Hospital
-
-
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
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
- Aged 18 years to 80 years, male or female;
- Diabetes mellitus(type 1 or 2);
- Moderately severe to severe NPDR (DRSS levels 47 or 53) which was confirmed by the central reading center, and in whom PRP can be safely deferred by the investigator's judgement;
- BCVA score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) using the ETDRS protocol at an initial testing distance of 4 meters;
- If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye;
Exclusion Criteria:
- Presence of DME threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye;
- Evidence of retinal neovascularization on clinical examination or FA;
- Any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or PRP in the study eye;
- Current ASNV, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involved the macular in the study eye;
- History of vitreoretinal surgery in the study eye;
- Active infectious blepharitis, keratitis, scleritis, conjunctivitis at the screening assessments in either eye ;
- Previous treatment with anti-angiogenic drugs in either eye or system (ranibizumab, aflibercept, conbercept, etc) within 3 months of the Day 0 visit;
- Previous use of intraocular or periocular corticosteroids (such as triamcinolone acetonide, dexamethasone vitreous implant) in either eye within 6 months of day 0.
- Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
- Pregnant or lactating women, subjects who had family planning throughout the study period;
- Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before theDay 0
- Those who considered unsuitable for enrollment by investigator.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intravitreal 1.0mg RC28-E injection Q8
Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.
|
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
|
Experimental: Experimental: intravitreal 1.0mg RC28-E injection PRN
Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 5 visits followed by injections an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria.
|
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
|
Experimental: Experimental: intravitreal 2.0mg RC28-E injection Q8
Subjects received 2.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.
|
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
|
Experimental: Experimental: intravitreal 2.0mg RC28-E injection PRN
Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 5 visits followed by injections an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria.
|
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52
Time Frame: At Week 24, 52
|
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time.
Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24, 52 from baseline
|
At Week 24, 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 24, 52
Time Frame: At Week 24, 52
|
Vision-threatening complications are defined as the composite outcome of proliferative diabetic retinopathy (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris and/or definitive neovascularization of the iridocorneal angle).
|
At Week 24, 52
|
Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 24, 52;
Time Frame: At Week 24, 52
|
The percentage of participants who developed CI-DME at week24, 52 were reported.
|
At Week 24, 52
|
Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);
Time Frame: Baseline up to week 52
|
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
|
Baseline up to week 52
|
Mean change from baseline in DRSS score;
Time Frame: Baseline upto week 52
|
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time.
Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24, 52 from baseline.
|
Baseline upto week 52
|
Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;
Time Frame: At Week 24, 52
|
The percentage of participants who received panretinal photocoagulation (PRP).
|
At Week 24, 52
|
Percentage of participants who undergoing Vitrectomy at Week24, 52;
Time Frame: At Week 24, 52
|
The percentage of participants who undergoing vitrectomy.
|
At Week 24, 52
|
Frequency of administration RC28-E;
Time Frame: At Week 24, 52
|
Number of intravitreal injections
|
At Week 24, 52
|
Safety of RC28-E injection
Time Frame: Baseline upto week 52
|
Incidence of AE in ocular and non-ocular
|
Baseline upto week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
May 25, 2021
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
March 1, 2021
First Submitted That Met QC Criteria
March 1, 2021
First Posted (Actual)
March 4, 2021
Study Record Updates
Last Update Posted (Actual)
October 11, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Diabetic Retinopathy
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- RC28-E protein
Other Study ID Numbers
- 28C003
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.
Clinical Trials on Diabetic Retinopathy
-
Retina Institute of HawaiiUnknownDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Severe Nonproliferative Diabetic Retinopathy | Mild Nonproliferative Diabetic Retinopathy | Moderate Nonproliferative Diabetic RetinopathyUnited States
-
University of CataniaUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyItaly
-
Asociación para Evitar la Ceguera en MéxicoCompletedProliferative Diabetic Retinopathy | Severe Nonproliferative | Active Photocoagulated Diabetic RetinopathyMexico
-
Asociación para Evitar la Ceguera en MéxicoUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyMexico
-
Asociación para Evitar la Ceguera en MéxicoUnknownNon Proliferative Diabetic Retinopathy. | Proliferative Diabetic Retinopathy.Mexico
-
Valo Health, Inc.RecruitingProliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
-
AEYE Health IncA. Stein Regulatory Affairs Consulting Ltd.RecruitingDiabetic Mellitus | Diabetic Retinopathy, DRUnited States
-
Ocuphire Pharma, Inc.CompletedDiabetic Retinopathy | Diabetic Macular Edema | NPDR - Non Proliferative Diabetic Retinopathy | PDR - Proliferative Diabetic RetinopathyUnited States
-
King Khaled Eye Specialist HospitalCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathySaudi Arabia
-
Retina Macula InstituteAllerganCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
Clinical Trials on RC28-E injection
-
RemeGen Co., Ltd.CompletedWet Age-Related Macular DegenerationChina
-
RemeGen Co., Ltd.Completed
-
RemeGen Co., Ltd.CompletedNeovascular Age-related Macular DegenerationChina
-
RemeGen Co., Ltd.Recruiting
-
Bonti, Inc.CompletedGlabellar Frown Lines (GL)United States
-
Rigshospitalet, DenmarkUnknownBreast Cancer | Ovarian Cancer | Neuroendocrine CarcinomaDenmark
-
Rigshospitalet, DenmarkUnknown
-
Rigshospitalet, DenmarkCompletedPET/CT Imaging of Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2Neuroendocrine TumorsDenmark
-
International Vaccine InstituteBill and Melinda Gates Foundation; Xiamen Innovax Biotech Co., LtdNot yet recruitingHepatitis E Virus Infection
-
Groupe Francophone des MyelodysplasiesCelgeneRecruitingMyelodysplastic Syndromes | MDSFrance