Diabetic Macular Edema
Conditions
Keywords
DME
Brief summary
This is a clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients.
Detailed description
This is an open, dose-escalation clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients in China.
Interventions
GENETICSKG0106 intravitreal injection dose level 1, 2 or 3
SKG0106 is a recombinant adeno-associated virus (rAAV) vector-based in vivo gene therapeutic product.
Sponsors
Wang Min
Lanyue Biotech (Hangzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained prior to all assessments. * Age ≥18 years at screening. * Type 1 or type 2 diabetes mellitus at screening. * Study eye criteria: * Decreased visual acuity attributable primarily to DME. * DME involves the macular center.
Exclusion criteria
* Active proliferative diabetic retinopathy in the study eye. * Any current or previous ocular disease in the study eye other than DME that could interfere with macular evaluation or affect central vision at screening or baseline. * Any active intraocular or periocular infection or active intraocular inflammation of the study eye at screening or baseline. * History of idiopathic or autoimmune uveitis in the study eye at screening or baseline. * Prior gene therapy in either eye. * History of vitreoretinal surgery in the study eye. * Uncontrolled blood pressure at screening or baseline defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg. * History of treated or untreated malignancy of any organ system within the past 5 years. * Pregnant or lactating women. * Women of reproductive age, defined as all women who are biologically capable of being pregnant, unless they use highly effective contraceptive methods between the time of study drug administration and 3 months after EOS (end of study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type, severity, and incidence of ocular and systemic AEs | AEs: Adverse Events | 48 weeks |
| Incidence of DLT | 4 weeks | DLT (Dose-limiting Toxicity) is judged by assessing the following AEs such as: * Severe visual acuity decline * Endoophthalmitis by investigator * Vitreous hemorrhage by investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in BCVA | 48 weeks | BCVA (Best Corrected Visual Acuity) of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing. |
| Mean change from baseline in CST | 48 weeks | CST (Central Subfield Thickness) is measured by Spectral domain optical coherence tomography (SD-OCT). |
| Mean change from baseline in patient-reported outcome (VFQ-25) scale score | 48 weeks | Both the total scale and subscale scores of the VFQ-25 (25-Item Visual Function Questionnaire) is ranging from 0 to 100, and higher scores mean a better outcome. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMin Wang, Doctor
Eye & ENT Hospital of Fudan University
Outcome results
None listed