Evaluation of RC28-E Injection in Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema
- Interventions
- Biological: intravitreal injection of RC28-EBiological: Conbercept
- Registration Number
- NCT04782115
- Lead Sponsor
- RemeGen Co., Ltd.
- Brief Summary
This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with diabetic macular edema.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
-
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);
-
The study eye must followed:
- 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.
- BCVA score in the study eye of 73 to 24 using the ETDRS protocol at an initial testing distance of 4 meters.
- 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.
- The macular edema caused by others instead of diabetes mellitus;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2.0mg RC28-E injection as needed intravitreal injection of RC28-E 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. 1.0mg RC28-E injection Q8 intravitreal injection of RC28-E 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. 1.0mg RC28-E injection as needed intravitreal injection of RC28-E 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. control group Conbercept 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. 2.0mg RC28-E injection Q8 intravitreal injection of RC28-E 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.
- Primary Outcome Measures
Name Time Method Mean change from baseline in BCVA at 52 week; Baseline, Week 52 Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Mean change from baseline in BCVA at 24 week; Baseline,week 24 BCVA=Best-corrected visual acuity;Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
- Secondary Outcome Measures
Name Time Method Safety of RC28-E injection Baseline up to Week 52 Incidence of AE in ocular and non-ocular
Percentage of subjects with VA worsen (who lost ≥5 letters, ≥10 letters, ≥15 letters in their BCVA) from baseline at 52 week; Baseline, Week 52 Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Mean change from baseline in BCVA at every visit during treatment period; Baseline up to Week 52 Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Percentage of subjects with BCVA ≥ 68 letters(a visual acuity Snellen equivalent of 20/40 or better) at 52 week; Baseline, Week 52 Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Frequency of administration RC28-E; Baseline, Week 52 Number of intravitreal injections
Mean change from baseline in central subfield thickness at 12, 24, 36, 52 week. 12, 24, 36, 52 week. Measurement of central subfield thickness by OCT.
Percentage of subjects with VA improvement (who gained >0 letters, ≥5 letters, ≥10 letters, ≥ 15 letters in their BCVA) from baseline at 52 week; Baseline up to Week 52 Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Trial Locations
- Locations (37)
People's Hospital of Ningxia Hui Autonomous Region
🇨🇳Yinchuan, Ningxia, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Hebei Eye Hospital
🇨🇳Xingtai, Hebei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Henan Provincial Eye Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First People's Hospital of Zunyi
🇨🇳Zunyi, Guizhou, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Zhengzhou Second Hospital
🇨🇳Zhengzhou, Henan, China
Shenyang He Eye Specialist Hospital
🇨🇳Shenyang, Liaoning, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Fourth People's Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Shanxi Eye Hospital
🇨🇳Taiyuan, Shanxi, China
The First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Beijing Aier Intech Eye Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Huizhou Central People's Hospital
🇨🇳Huizhou, Guangdong, China
Zhongshan Ophthalmic Center of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
CNPC Central Hospital
🇨🇳Langfang, Hebei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The Affiliated Eye Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Affiliated Eye Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
Weifang Eye Hospital
🇨🇳Weifang, Shandong, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Ruian People's Hospital
🇨🇳Rui'an, Zhejiang, China