Evaluation of RC28-E Injection in Diabetic Retinopathy (NCT04782128) | Clinical Trial Compass
UnknownPhase 2
Evaluation of RC28-E Injection in Diabetic Retinopathy
China120 participantsStarted 2021-05-25
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 triamci…
What they're measuring
1
The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52