Clinical trial NCT04782128: Evaluation of RC28-E Injection in Diabetic Retinopathy
Official title: A Randomized, Open-label, Multicenter Study of the Efficacy and Safety of RC28-E Injection in Subjects With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Diabetic Retinopathy
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy.


Eligibility criteria: 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);
* Moderately severe to severe NPDR (DRSS levels 47 or 53) which was confirmed by the central reading center, and in whom PRP can be safely deferred by the investigator's judgement;
* BCVA score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) using the ETDRS protocol at an initial testing distance of 4 meters;
* If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye;

Exclusion Criteria:

* Presence of DME threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye;
* Evidence of retinal neovascularization on clinical examination or FA;
* Any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or PRP in the study eye;
* Current ASNV, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involved the macular in the study eye;
* History of vitreoretinal surgery in the study eye;
* Active infectious blepharitis, keratitis, scleritis, conjunctivitis at the screening assessments 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 visit;
* Previous use of intraocular or periocular corticosteroids (such as triamcinolone acetonide, dexamethasone vitreous implant) in either eye within 6 months of day 0.
* Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
* Pregnant or lactating women, subjects who had family planning throughout the study period;
* Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before theDay 0
* Those who considered unsuitable for enrollment by investigator.

Primary outcomes:
measure: The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52
timeFrame: At Week 24, 52
Secondary outcomes:
measure: Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 24, 52
timeFrame: At Week 24, 52
measure: Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 24, 52;
timeFrame: At Week 24, 52
measure: Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);
timeFrame: Baseline up to week 52
measure: Mean change from baseline in DRSS score;
timeFrame: Baseline upto week 52
measure: Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;
timeFrame: At Week 24, 52
measure: Percentage of participants who undergoing Vitrectomy at Week24, 52;
timeFrame: At Week 24, 52
measure: Frequency of administration RC28-E;
timeFrame: At Week 24, 52
measure: Safety of RC28-E injection
timeFrame: Baseline upto week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
References: