Evaluation of RC28-E Injection in Diabetic Macular Edema

RemeGen

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Biological: Conbercept; Biological: intravitreal injection of RC28-E

Study type: Interventional

Funder types: Industry

Identifiers

NCT04782115

28C002

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 5 patient groups

1.0mg RC28-E injection Q8

Experimental group

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.

Treatment:

Biological: intravitreal injection of RC28-E

1.0mg RC28-E injection as needed

Experimental group

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.

Treatment:

Biological: intravitreal injection of RC28-E

2.0mg RC28-E injection Q8

Experimental group

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.

Treatment:

Biological: intravitreal injection of RC28-E

2.0mg RC28-E injection as needed

Experimental group

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.

Treatment:

Biological: intravitreal injection of RC28-E

control group

Experimental group

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.

Treatment:

Biological: Conbercept