Evaluation of RC28-E Injection in Diabetic Retinopathy

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

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.

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.