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| Name | Class |
|---|---|
| Shanghai Refreshgene Technology Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RRG001 | Experimental | Frequency of administration: one time injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RRG001 | Drug | Administered by subretinal injection. Dosage form: injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To 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 | 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 | Within 24 weeks after RRG001 administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 24 weeks after RRG001 administration |
| To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects |
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Inclusion Criteria:
Exclusion Criteria:
Study Eye-Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin medical university eye hospital | Recruiting | Tianjin | China |
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To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects |
| 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 | 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 | Within 24 weeks after RRG001 administration |
| 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 | 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 | 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 | Within 24 weeks after RRG001 administration |