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Evaluation of RC28-E Injection in Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

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

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

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);

  • 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.

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

control group

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
Mean change from baseline in BCVA at 52 week;
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Secondary Outcome Measures

Mean change from baseline in BCVA at every visit during treatment period;
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Mean change from baseline in central subfield thickness at 12, 24, 36, 52 week.
Measurement of central subfield thickness by OCT.
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.
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.
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.
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
August 30, 2023
Sponsor
RemeGen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04782115
Brief Title
Evaluation of RC28-E Injection in Diabetic Macular Edema
Official Title
Protein by Dual Blockage of VEGF and FGF-2) in Subjects With Diabetic Macular Edema.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

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 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1.0mg RC28-E injection Q8
Arm Type
Experimental
Arm Description
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.
Arm Title
1.0mg RC28-E injection as needed
Arm Type
Experimental
Arm Description
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.
Arm Title
2.0mg RC28-E injection Q8
Arm Type
Experimental
Arm Description
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.
Arm Title
2.0mg RC28-E injection as needed
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
intravitreal injection of RC28-E
Intervention Description
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
Intervention Type
Biological
Intervention Name(s)
Conbercept
Intervention Description
KH902(Conbercept）
Primary Outcome Measure Information:
Title
Mean change from baseline in BCVA at 24 week;
Description
BCVA=Best-corrected visual acuity;Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline,week 24
Title
Mean change from baseline in BCVA at 52 week;
Description
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Mean change from baseline in BCVA at every visit during treatment period;
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 central subfield thickness at 12, 24, 36, 52 week.
Description
Measurement of central subfield thickness by OCT.
Time Frame
12, 24, 36, 52 week.
Title
Percentage of subjects with VA improvement (who gained >0 letters, ≥5 letters, ≥10 letters, ≥ 15 letters in their BCVA) from baseline at 52 week;
Description
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline up to Week 52
Title
Percentage of subjects with VA worsen (who lost ≥5 letters, ≥10 letters, ≥15 letters in their BCVA) from baseline at 52 week;
Description
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline, Week 52
Title
Percentage of subjects with BCVA ≥ 68 letters(a visual acuity Snellen equivalent of 20/40 or better) at 52 week;
Description
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline, Week 52
Title
Frequency of administration RC28-E;
Description
Number of intravitreal injections
Time Frame
Baseline, Week 52
Title
Safety of RC28-E injection
Description
Incidence of AE in ocular and non-ocular
Time Frame
Baseline up to 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); 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; 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.
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of RC28-E Injection in Diabetic Macular Edema

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