Evaluation of RC28-E Injection in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Protein by Dual Blockage of VEGF and FGF-2) in Subjects With Diabetic Macular Edema.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782115
• Other study ID #: 28C002
• Status: Completed
• Phase: Phase 2
• Start date: March 17, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: December 2023
• Source: RemeGen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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);

• 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:

• 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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Biological:
• intravitreal injection of RC28-E
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
• Conbercept
KH902(Conbercept)

Locations

Country	Name	City	State
China	Beijing Aier Intech Eye Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Zhongshan Ophthalmic Center of Sun Yat-sen University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Huizhou Central People's Hospital	Huizhou	Guangdong
China	CNPC Central Hospital	Langfang	Hebei
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	The Affiliated Eye Hospital of Nanchang University	Nanchang	Jiangxi
China	The Affiliated Eye Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Ruian People's Hospital	Rui'an	Zhejiang
China	Shenyang He Eye Specialist Hospital	Shenyang	Liaoning
China	The Fourth People's Hospital of Shenyang	Shenyang	Liaoning
China	Shanxi Eye Hospital	Taiyuan	Shanxi
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Weifang Eye Hospital	Weifang	Shandong
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Hebei Eye Hospital	Xingtai	Hebei
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia
China	Henan Provincial Eye Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Zhengzhou Second Hospital	Zhengzhou	Henan
China	The First People's Hospital of Zunyi	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in BCVA at 24 week;	BCVA=Best-corrected visual acuity;Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline,week 24
Primary	Mean change from baseline in BCVA at 52 week;	Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Week 52
Secondary	Mean change from baseline in BCVA at every visit during treatment period;	Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline up to Week 52
Secondary	Mean change from baseline in central subfield thickness at 12, 24, 36, 52 week.	Measurement of central subfield thickness by OCT.	12, 24, 36, 52 week.
Secondary	Percentage of subjects with VA improvement (who gained >0 letters, =5 letters, =10 letters, = 15 letters in their BCVA) from baseline at 52 week;	Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline up to Week 52
Secondary	Percentage of subjects with VA worsen (who lost =5 letters, =10 letters, =15 letters in their BCVA) from baseline at 52 week;	Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Week 52
Secondary	Percentage of subjects with BCVA = 68 letters(a visual acuity Snellen equivalent of 20/40 or better) at 52 week;	Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Week 52
Secondary	Frequency of administration RC28-E;	Number of intravitreal injections	Baseline, Week 52
Secondary	Safety of RC28-E injection	Incidence of AE in ocular and non-ocular	Baseline up to Week 52