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Evaluation of RC28-E Injection in Diabetic Retinopathy

Primary Purpose

Diabetic Retinopathy

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
RC28-E injection
Sponsored by
RemeGen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

intravitreal 1.0mg RC28-E injection Q8

Experimental: intravitreal 1.0mg RC28-E injection PRN

Experimental: intravitreal 2.0mg RC28-E injection Q8

Experimental: intravitreal 2.0mg RC28-E injection PRN

Arm Description

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

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 24, 52
Vision-threatening complications are defined as the composite outcome of proliferative diabetic retinopathy (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris and/or definitive neovascularization of the iridocorneal angle).
Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 24, 52;
The percentage of participants who developed CI-DME at week24, 52 were reported.
Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Mean change from baseline in DRSS score;
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.
Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;
The percentage of participants who received panretinal photocoagulation (PRP).
Percentage of participants who undergoing Vitrectomy at Week24, 52;
The percentage of participants who undergoing vitrectomy.
Frequency of administration RC28-E;
Number of intravitreal injections
Safety of RC28-E injection
Incidence of AE in ocular and non-ocular

Full Information

First Posted
March 1, 2021
Last Updated
October 10, 2023
Sponsor
RemeGen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04782128
Brief Title
Evaluation of RC28-E Injection in Diabetic Retinopathy
Official Title
A Randomized, Open-label, Multicenter Study of the Efficacy and Safety of RC28-E Injection in Subjects With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravitreal 1.0mg RC28-E injection Q8
Arm Type
Experimental
Arm Description
Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.
Arm Title
Experimental: intravitreal 1.0mg RC28-E injection PRN
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental: intravitreal 2.0mg RC28-E injection Q8
Arm Type
Experimental
Arm Description
Subjects received 2.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.
Arm Title
Experimental: intravitreal 2.0mg RC28-E injection PRN
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
RC28-E injection
Intervention Description
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
Primary Outcome Measure Information:
Title
The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52
Description
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
Time Frame
At Week 24, 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 24, 52
Description
Vision-threatening complications are defined as the composite outcome of proliferative diabetic retinopathy (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris and/or definitive neovascularization of the iridocorneal angle).
Time Frame
At Week 24, 52
Title
Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 24, 52;
Description
The percentage of participants who developed CI-DME at week24, 52 were reported.
Time Frame
At Week 24, 52
Title
Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);
Description
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline up to week 52
Title
Mean change from baseline in DRSS score;
Description
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.
Time Frame
Baseline upto week 52
Title
Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;
Description
The percentage of participants who received panretinal photocoagulation (PRP).
Time Frame
At Week 24, 52
Title
Percentage of participants who undergoing Vitrectomy at Week24, 52;
Description
The percentage of participants who undergoing vitrectomy.
Time Frame
At Week 24, 52
Title
Frequency of administration RC28-E;
Description
Number of intravitreal injections
Time Frame
At Week 24, 52
Title
Safety of RC28-E injection
Description
Incidence of AE in ocular and non-ocular
Time Frame
Baseline upto week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of RC28-E Injection in Diabetic Retinopathy

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