Diabetic Macular Edema
Conditions
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.
Interventions
BIOLOGICALRC-28E
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
BIOLOGICALAflibercept
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in BCVA at Week 52 | Baseline, 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52 | Baseline, week 52 | Proportion of patients of reducing 4 types of letter counting in BCVA, respectively |
| Average change in BCVA from baseline over the period week 40 through week 52 | Baseline, weeks 40, 44, 48 and 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 | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | BCVA will be assessed at each visit |
| Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52 | Baseline, week 52 | Proportion of patients of gaining 4 types of letter counting in BCVA, respectively |
| Change from baseline in CST at Week 52 | Baseline, week 52 | CST=central subfield thickness |
| Mean change from baseline in CST over a period of week 40 through week 52 | Baseline, weeks 40, 44, 48 and 52. | CST=central subfield thickness |
| Change from baseline in CST over time | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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 | Baseline, week 52 | Proportion of patients whose intraretinal fluid are completely improved |
| Proportion of patients with absence of subretinal fluid at Week 52 | Baseline, 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 | Baseline, 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 | Baseline, week 52 | DRSS=Diabetic Retinopathy Severity Scale |
| Proportion of patients who develop new PDR or high risk PDR at Week 52 | Baseline, week 52 | PDR=proliferative diabetic retinopathy |
| Incidence and severity of ocular adverse events and non-ocular adverse events | 0~52 weeks | during the study |
| Plasma concentration of RC28-E over time | Baseline, weeks 16, 36 and 48 | during the study |
| Presence of ADAs during the study relative to the presence of ADAs at baseline | Baseline, weeks 12, 24, 36 and 52 | during the study |
Countries
China
Contacts
Primary ContactBinghua Xiao
Outcome results
None listed