Evaluation of RC28-E Injection in Diabetic Retinopathy | NCT04782128

NCT04782128

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intravitreal 1.0mg RC28-E injection Q8	Experimental	Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.	Biological: RC28-E injection
Experimental: intravitreal 1.0mg RC28-E injection PRN	Experimental	Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 5 visits followed by injections an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria.	Biological: RC28-E injection
Experimental: intravitreal 2.0mg RC28-E injection Q8	Experimental	Subjects received 2.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.	Biological: RC28-E injection
Experimental: intravitreal 2.0mg RC28-E injection PRN	Experimental	Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 5 visits followed by injections an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria.	Biological: RC28-E injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RC28-E injection	Biological	a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF	Experimental: intravitreal 1.0mg RC28-E injection PRN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52	The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24, 52 from baseline	At Week 24, 52

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 24, 52	Vision-threatening complications are defined as the composite outcome of proliferative diabetic retinopathy (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris and/or definitive neovascularization of the iridocorneal angle).

Eligibility Module

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.