This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with diabetic macular edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
KH902(Conbercept)
Mean change from baseline in BCVA at 24 week;
BCVA=Best-corrected visual acuity;Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline,week 24
Mean change from baseline in BCVA at 52 week;
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline, Week 52
Mean change from baseline in BCVA at every visit during treatment period;
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline up to Week 52
Mean change from baseline in central subfield thickness at 12, 24, 36, 52 week.
Measurement of central subfield thickness by OCT.
Time frame: 12, 24, 36, 52 week.
Percentage of subjects with VA improvement (who gained >0 letters, ≥5 letters, ≥10 letters, ≥ 15 letters in their BCVA) from baseline at 52 week;
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline up to Week 52
Percentage of subjects with VA worsen (who lost ≥5 letters, ≥10 letters, ≥15 letters in their BCVA) from baseline at 52 week;
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline, Week 52
Percentage of subjects with BCVA ≥ 68 letters(a visual acuity Snellen equivalent of 20/40 or better) at 52 week;
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Aier Intech Eye Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhongshan Ophthalmic Center of Sun Yat-sen University
Guangzhou, Guangdong, China
...and 27 more locations
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline, Week 52
Frequency of administration RC28-E;
Number of intravitreal injections
Time frame: Baseline, Week 52
Safety of RC28-E injection
Incidence of AE in ocular and non-ocular
Time frame: Baseline up to Week 52