Back to resultsEfficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
RC-28E
Aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria: Documented diagnosed with type I or type II diabetes mellitus. Hemoglobin A1c (HBA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1. Ability and willingness to undertake all scheduled visits and assessments. The study eye must meet the following requirements: macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea. decreased visual acuity attributable primarily to DME, the best corrected visual acuity (BCVA) 19 or more letters, 78 letters or less. Exclusion Criteria: The study eye with high risk of proliferative diabetic retinopathy. The macular edema of the study eye is mainly caused by other diseases or factors other than DME. Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye. Administration of IVT any other anti-VEGF drugs in the study eye within 3 months and/or in the other eye within 7 days prior to Day 1. Any intraocular long-acting or sustained release corticosteroid treatment (e.g., dexamethasone intravitreal implant) in the study eye within 6 months prior to Day 1. Active intraocular or periocular infection or active intraocular inflammation in either eye. The study eye with poorly controlled glaucoma. A history of idiopathic or autoimmune related uveitis in either eye. History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1. Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest. Currently pregnant or breastfeeding, or intend to become pregnant during the study. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye. Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye. Other protocol-specified inclusion/exclusion criteria may apply.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RC-28E
Aflibercept
Arm Description
RC-28E 2.0 mg will be initially intravitreal injected (IVT) 5 times at 4 week intervals from week 0 to week 16, then every 8 weeks until week 48.
Aflibercept 2.0mg will be received IVT once every 4 weeks for 5 consecutive times from week 0 to week 16, then once every 8 weeks till week 48.
Outcomes
Primary Outcome Measures
Change from baseline in BCVA at Week 52
BCVA=best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a starting distance of 4 meters
Secondary Outcome Measures
Average change in BCVA from baseline over the period week 40 through week 52
For each subject, this endpoint is defined as the average of the changes from baseline to weeks 40, 44, 48 and 52
Change from baseline in BCVA over time
BCVA will be assessed at each visit
Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Proportion of patients of gaining 4 types of letter counting in BCVA, respectively
Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Proportion of patients of reducing 4 types of letter counting in BCVA, respectively
Change from baseline in CST at Week 52
CST=central subfield thickness
Mean change from baseline in CST over a period of week 40 through week 52
CST=central subfield thickness
Change from baseline in CST over time
The change of CST will be assessed from baseline to 52 weeks by every 4 week intervals
Proportion of patients with absence of intraretinal fluid at Week 52
Proportion of patients whose intraretinal fluid are completely improved
Proportion of patients with absence of subretinal fluid at Week 52
Proportion of patients whose subretinal fluid are completely improved
Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52
Proportion of patients whose intraretinal fluid and subretinal fluid are both completely improved
Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52
DRSS=Diabetic Retinopathy Severity Scale
Proportion of patients who develop new PDR or high risk PDR at Week 52
PDR=proliferative diabetic retinopathy
Incidence and severity of ocular adverse events and non-ocular adverse events
during the study
Plasma concentration of RC28-E over time
during the study
Presence of ADAs during the study relative to the presence of ADAs at baseline
during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05885503
Brief Title
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
Official Title
A Phase III, Multicenter, Randomized, Double-blind, Active Controlled Trial of RC28-E Intravitreal Injection in Subjects With Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (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
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RC-28E
Arm Type
Experimental
Arm Description
RC-28E 2.0 mg will be initially intravitreal injected (IVT) 5 times at 4 week intervals from week 0 to week 16, then every 8 weeks until week 48.
Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
Aflibercept 2.0mg will be received IVT once every 4 weeks for 5 consecutive times from week 0 to week 16, then once every 8 weeks till week 48.
Intervention Type
Biological
Intervention Name(s)
RC-28E
Intervention Description
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
Intervention Type
Biological
Intervention Name(s)
Aflibercept
Intervention Description
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
Primary Outcome Measure Information:
Title
Change from baseline in BCVA at Week 52
Description
BCVA=best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a starting distance of 4 meters
Time Frame
Baseline, week 52
Secondary Outcome Measure Information:
Title
Average change in BCVA from baseline over the period week 40 through week 52
Description
For each subject, this endpoint is defined as the average of the changes from baseline to weeks 40, 44, 48 and 52
Time Frame
Baseline, weeks 40, 44, 48 and 52
Title
Change from baseline in BCVA over time
Description
BCVA will be assessed at each visit
Time Frame
Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Title
Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Description
Proportion of patients of gaining 4 types of letter counting in BCVA, respectively
Time Frame
Baseline, week 52
Title
Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Description
Proportion of patients of reducing 4 types of letter counting in BCVA, respectively
Time Frame
Baseline, week 52
Title
Change from baseline in CST at Week 52
Description
CST=central subfield thickness
Time Frame
Baseline, week 52
Title
Mean change from baseline in CST over a period of week 40 through week 52
Description
CST=central subfield thickness
Time Frame
Baseline, weeks 40, 44, 48 and 52.
Title
Change from baseline in CST over time
Description
The change of CST will be assessed from baseline to 52 weeks by every 4 week intervals
Time Frame
Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Title
Proportion of patients with absence of intraretinal fluid at Week 52
Description
Proportion of patients whose intraretinal fluid are completely improved
Time Frame
Baseline, week 52
Title
Proportion of patients with absence of subretinal fluid at Week 52
Description
Proportion of patients whose subretinal fluid are completely improved
Time Frame
Baseline, week 52
Title
Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52
Description
Proportion of patients whose intraretinal fluid and subretinal fluid are both completely improved
Time Frame
Baseline, week 52
Title
Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52
Description
DRSS=Diabetic Retinopathy Severity Scale
Time Frame
Baseline, week 52
Title
Proportion of patients who develop new PDR or high risk PDR at Week 52
Description
PDR=proliferative diabetic retinopathy
Time Frame
Baseline, week 52
Title
Incidence and severity of ocular adverse events and non-ocular adverse events
Description
during the study
Time Frame
0~52 weeks
Title
Plasma concentration of RC28-E over time
Description
during the study
Time Frame
Baseline, weeks 16, 36 and 48
Title
Presence of ADAs during the study relative to the presence of ADAs at baseline
Description
during the study
Time Frame
Baseline, weeks 12, 24, 36 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented diagnosed with type I or type II diabetes mellitus.
Hemoglobin A1c (HBA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1.
Ability and willingness to undertake all scheduled visits and assessments.
The study eye must meet the following requirements:
macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea.
decreased visual acuity attributable primarily to DME, the best corrected visual acuity (BCVA) 19 or more letters, 78 letters or less.
Exclusion Criteria:
The study eye with high risk of proliferative diabetic retinopathy.
The macular edema of the study eye is mainly caused by other diseases or factors other than DME.
Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye.
Administration of IVT any other anti-VEGF drugs in the study eye within 3 months and/or in the other eye within 7 days prior to Day 1.
Any intraocular long-acting or sustained release corticosteroid treatment (e.g., dexamethasone intravitreal implant) in the study eye within 6 months prior to Day 1.
Active intraocular or periocular infection or active intraocular inflammation in either eye.
The study eye with poorly controlled glaucoma.
A history of idiopathic or autoimmune related uveitis in either eye.
History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1.
Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest.
Currently pregnant or breastfeeding, or intend to become pregnant during the study.
Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye.
Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye.
Other protocol-specified inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binghua Xiao
Phone
86-010-58076833
Email
xiaosir522@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youxin Chen
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youxin Chen, M.D.
Phone
13801025972
Email
chenyouxinpumch@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
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