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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
Beijing Hospital
Beijing, Beijing Municipality, China
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
Time frame: At Week 24, 52
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).
Time frame: At Week 24, 52
Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 24, 52;
The percentage of participants who developed CI-DME at week24, 52 were reported.
Time frame: At Week 24, 52
Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline up to week 52
Mean change from baseline in DRSS score;
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.
Time frame: Baseline upto week 52
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Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;
The percentage of participants who received panretinal photocoagulation (PRP).
Time frame: At Week 24, 52
Percentage of participants who undergoing Vitrectomy at Week24, 52;
The percentage of participants who undergoing vitrectomy.
Time frame: At Week 24, 52
Frequency of administration RC28-E;
Number of intravitreal injections
Time frame: At Week 24, 52
Safety of RC28-E injection
Incidence of AE in ocular and non-ocular
Time frame: Baseline upto week 52