Evaluation of RC28-E Injection in Diabetic Retinopathy

NCT ID: NCT04782128

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2024-07-31

Brief Summary

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.

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RC28-E injection

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

RC28-E injection

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

RC28-E injection

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

RC28-E injection

Intervention Type: BIOLOGICAL

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

Interventions

RC28-E injection

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RemeGen Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

28C003

Identifier Type: -

Identifier Source: org_study_id