This study aims to slow down disease progression, reduce postoperative complications and decrease retreatment frequency in subjects with proliferative diabetic retinopathy (PDR) by administering a single subretinal injection of RRG001 gene therapy after vitrectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Administered by subretinal injection. Dosage form: injection.
Tianjin medical university eye hospital
Tianjin, China
RECRUITINGTo evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
Time frame: Within 28 days after RRG001 administration
To evaluate the incidence of AEs(Adverse Event) as assessed CTCAE 5.0 at most 6 subjcts
To evaluate the incidence of AEs as assessed CTCAE 5.0 at most 6 subjcts
Time frame: Within 24 weeks after RRG001 administration
To evaluate the disease progression as assessed the vitreous hemorrhage of the study eye at most 6 subjects
To evaluate the disease progression as assessed the vitreous hemorrhage of the study eye at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects
To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the frequency for rescue therapy of the study eye at most 6 subjects
To evaluate the frequency for rescue therapy of the study eye at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the change from baseline in BCVA(Best Corrected Visual Acuity) of the study eye as assessed by ETDRS chart at most 6 subjects
To evaluate the change from baseline in BCVA of the study eye as assessed by ETDRS chart at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
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To evaluate the anatomical changes of the study eye by OCT(optical coherence tomography) at most 6 subjects
To evaluate the anatomical changes of the study eye by OCT(optical coherence tomography) at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the anatomical changes of the study eye by CFP(colour fundus photography)at most 6 subjects
To evaluate the anatomical changes of the study eye by CFP(colour fundus photography)at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the anatomical changes of the study eye by OCTA(optical coherence tomography angiography) at most 6 subjects
To evaluate the anatomical changes of the study eye by OCTA(optical coherence tomography angiography) at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration