Status:
UNKNOWN
Evaluation of RC28-E Injection in Diabetic Retinopathy
Lead Sponsor:
RemeGen Co., Ltd.
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04782128
Start Date
May 25 2021
End Date
July 1 2024
Last Update
October 11 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730