Evaluation of RC28-E Injection in Diabetic Macular Edema

Phase 2

Completed

• Conditions: Diabetic Macular Edema

• Registration Number: NCT04782115
• Lead Sponsor: RemeGen Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-03-17
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in BCVA at 52 week;	Baseline, Week 52	Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Mean change from baseline in BCVA at 24 week;	Baseline,week 24	BCVA=Best-corrected visual acuity;Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Secondary Outcome Measures

Name	Time	Method
Safety of RC28-E injection	Baseline up to Week 52	Incidence of AE in ocular and non-ocular
Percentage of subjects with VA worsen (who lost ≥5 letters, ≥10 letters, ≥15 letters in their BCVA) from baseline at 52 week;	Baseline, Week 52	Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Mean change from baseline in BCVA at every visit during treatment period;	Baseline up to Week 52	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;	Baseline, Week 52	Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Frequency of administration RC28-E;	Baseline, Week 52	Number of intravitreal injections
Mean change from baseline in central subfield thickness at 12, 24, 36, 52 week.	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;	Baseline up to Week 52	Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Trial Locations

Locations (37)

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Aier Intech Eye Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Zhongshan Ophthalmic Center of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

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