Evaluation of RC28-E Injection in Diabetic Macular Edema

NCT04782115 | Completed Phase 2

• 1 other identifier: 28C002
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 37

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Mean change from baseline in BCVA at every visit during treatment period;

  Baseline up to Week 52

• Mean change from baseline in central subfield thickness at 12, 24, 36, 52 week.

  12, 24, 36, 52 week.

• 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

• 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

• Percentage of subjects with BCVA ≥ 68 letters(a visual acuity Snellen equivalent of 20/40 or better) at 52 week;

  Baseline, Week 52

Study Arms (5)

1.0mg RC28-E injection Q8

EXPERIMENTAL

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.

Biological: intravitreal injection of RC28-E

1.0mg RC28-E injection as needed

EXPERIMENTAL

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.

Biological: intravitreal injection of RC28-E

2.0mg RC28-E injection Q8

EXPERIMENTAL

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.

Biological: intravitreal injection of RC28-E

2.0mg RC28-E injection as needed

EXPERIMENTAL

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.

Biological: intravitreal injection of RC28-E

control group

EXPERIMENTAL

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.

Biological: Conbercept

Interventions

intravitreal injection of RC28-E BIOLOGICAL

a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF

1.0mg RC28-E injection Q8; 1.0mg RC28-E injection as needed; 2.0mg RC28-E injection Q8; 2.0mg RC28-E injection as needed

Conbercept BIOLOGICAL

KH902(Conbercept）

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (37)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

Location

Beijing Aier Intech Eye Hospital

Beijing, Beijing Municipality, China

Location

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Zhongshan Ophthalmic Center of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Huizhou Central People's Hospital

Huizhou, Guangdong, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

The First People's Hospital of Zunyi

Zunyi, Guizhou, China

Location

CNPC Central Hospital

Langfang, Hebei, China

Location

Hebei Eye Hospital

Xingtai, Hebei, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Henan Provincial Eye Hospital

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Zhengzhou Second Hospital

Zhengzhou, Henan, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Location

The Affiliated Eye Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Location

The Affiliated Eye Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, China

Location

Shenyang He Eye Specialist Hospital

Shenyang, Liaoning, China

Location

The Fourth People's Hospital of Shenyang

Shenyang, Liaoning, China

Location

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

Location

Weifang Eye Hospital

Weifang, Shandong, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Location

Shanxi Eye Hospital

Taiyuan, Shanxi, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Ruian People's Hospital

Rui’an, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 40122579 DERIVED

MeSH Terms

Interventions

KH902 fusion protein

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: March 17, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

CN (37)