Clinical trial NCT05885503: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in BCVA at Week 52
timeFrame: Baseline, week 52
Secondary outcomes:
measure: Average change in BCVA from baseline over the period week 40 through week 52
timeFrame: Baseline, weeks 40, 44, 48 and 52
measure: Change from baseline in BCVA over time
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
timeFrame: Baseline, week 52
measure: Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
timeFrame: Baseline, week 52
measure: Change from baseline in CST at Week 52
timeFrame: Baseline, week 52
measure: Mean change from baseline in CST over a period of week 40 through week 52
timeFrame: Baseline, weeks 40, 44, 48 and 52.
measure: Change from baseline in CST over time
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Proportion of patients with absence of intraretinal fluid at Week 52
timeFrame: Baseline, week 52
measure: Proportion of patients with absence of subretinal fluid at Week 52
timeFrame: Baseline, week 52
measure: Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52
timeFrame: Baseline, week 52
measure: Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52
timeFrame: Baseline, week 52
measure: Proportion of patients who develop new PDR or high risk PDR at Week 52
timeFrame: Baseline, week 52
measure: Incidence and severity of ocular adverse events and non-ocular adverse events
timeFrame: 0~52 weeks
measure: Plasma concentration of RC28-E over time
timeFrame: Baseline, weeks 16, 36 and 48
measure: Presence of ADAs during the study relative to the presence of ADAs at baseline
timeFrame: Baseline, weeks 12, 24, 36 and 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Youxin Chen
role: PRINCIPAL_INVESTIGATOR
References: