Evaluation of RC28-E Injection in Diabetic Macular Edema
NCT ID: NCT04782115
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2021-03-17
2023-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of RC28-E Injection in Diabetic Retinopathy
NCT04782128
Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
NCT02194634
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
NCT05885503
Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy
NCT06305143
Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema
NCT04668703
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1.0mg RC28-E injection Q8
In the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 1.0 mg RC28-E every 4 weeks, for 3 consecutive times; From then on to the 48th week, the patients were visited every 4 weeks and given medicine every 8 weeks.
intravitreal injection of RC28-E
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
1.0mg RC28-E injection as needed
In the loading phase (from week 0 to week 16), the study eye will receive intravitreal injection of 1.0mg RC28-E every 4 weeks, for 5 consecutive times;In the as needed (pro re nata,PRN)phase (from then on to week 48), the study eye will receive the same dose on an PRN schedule based upon the physician assessment in accordance with pre-specified criteria.
intravitreal injection of RC28-E
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
2.0mg RC28-E injection Q8
In the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 2.0mg RC28-E every 4 weeks, for 3 consecutive times; From then on to the 48th week, the patients were visited every 4 weeks and given medicine every 8 weeks.
intravitreal injection of RC28-E
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
2.0mg RC28-E injection as needed
In the loading phase (from week 0 to week 16), the study eye will receive intravitreal injection of 2.0mg RC28-E every 4 weeks, for 5 consecutive times;In the as needed (pro re nata,PRN)phase (from then on to week 48), the study eye will receive the same dose on an PRN schedule based upon the physician assessment in accordance with pre-specified criteria.
intravitreal injection of RC28-E
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
control group
In the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of Conbercept every 4 weeks, for 3 consecutive times;In the as needed (pro re nata,PRN)phase (from then on to week 48), the study eye will receive the same dose on an PRN schedule based upon the physician assessment in accordance with pre-specified criteria.
Conbercept
KH902(Conbercept）
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
intravitreal injection of RC28-E
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
Conbercept
KH902(Conbercept）
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged 18 years to 80 years, male or female;
* Diabetes mellitus(type 1 or 2);
* The study eye must followed:
1. Retinal thickening secondary to diabetes mellitus (DME) involving the center of the fovea; Decrease in vision determined to be primarily the result of DME and not to other causes.
2. BCVA score in the study eye of 73 to 24 using the ETDRS protocol at an initial testing distance of 4 meters.
3. The central subfield thickness ≥300μm in the center subfield as assessed on OCT by the reading center;
* If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye; the researchers judged that the fellow eye should not be treated with other anti-VEGF drugs recently.
Exclusion Criteria
* Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates;
* Current iris neovascularization, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involving the macula in the study eye;
* Only one functional eye even if that eye is otherwise eligible for the study;
* Evidence of periocular or intraocular inflammation or infection including infectious blepharitis, keratitis, scleritis, conjunctivitis, endophthalmitis or uveitis at screening assessment 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;
* History of cardiovascular and cerebrovascular events within 6 months of screening visit: myocardial infarction, unstable angina pectoris, ventricular arrhythmias, New York heart association grade II + heart failure, stroke, etc.;
* Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
* Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before the baseline period;
* Those who considered unsuitable for enrollment by investigator.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RemeGen Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Aier Intech Eye Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhongshan Ophthalmic Center of Sun Yat-sen University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The First People's Hospital of Zunyi
Zunyi, Guizhou, China
CNPC Central Hospital
Langfang, Hebei, China
Hebei Eye Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial Eye Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhengzhou Second Hospital
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Shenyang He Eye Specialist Hospital
Shenyang, Liaoning, China
The Fourth People's Hospital of Shenyang
Shenyang, Liaoning, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China
Weifang Eye Hospital
Weifang, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Ruian People's Hospital
Rui’an, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zhang W, Cheng S, Gu X, Liu X, Dai H, Zhuang W, Sun B, Gao L, Sun X, Zhang M, Song Z, Wang W, Li L, Chen H, Fang J, Chen Y. Simultaneous inhibition of fibroblast growth factor-2 and vascular endothelial growth factor-a with RC28-E in diabetic macular edema: a phase 2 randomised trial. Br J Ophthalmol. 2025 Jun 23;109(7):784-790. doi: 10.1136/bjo-2024-326006.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
28C002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.