Evaluation of RC28-E Injection in Diabetic Retinopathy

NCT04782128 | Unknown Phase 2

• 1 other identifier: 28C003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52

  The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24, 52 from baseline

  At Week 24, 52

Secondary Outcomes (8)

• Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 24, 52

  At Week 24, 52

• Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 24, 52;

  At Week 24, 52

• Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);

  Baseline up to week 52

• Mean change from baseline in DRSS score;

  Baseline upto week 52

• Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;

  At Week 24, 52

Study Arms (4)

intravitreal 1.0mg RC28-E injection Q8

EXPERIMENTAL

Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.

Biological: RC28-E injection

Experimental: intravitreal 1.0mg RC28-E injection PRN

EXPERIMENTAL

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.

Biological: RC28-E injection

Experimental: intravitreal 2.0mg RC28-E injection Q8

EXPERIMENTAL

Subjects received 2.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.

Biological: RC28-E injection

Experimental: intravitreal 2.0mg RC28-E injection PRN

EXPERIMENTAL

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.

Biological: RC28-E injection

Interventions

RC28-E injection BIOLOGICAL

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

Experimental: intravitreal 1.0mg RC28-E injection PRN; Experimental: intravitreal 2.0mg RC28-E injection PRN; Experimental: intravitreal 2.0mg RC28-E injection Q8; intravitreal 1.0mg RC28-E injection Q8

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);
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

RC28-E protein

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

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: May 25, 2021
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

CN (1)