Overview
This is a clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients.
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.
Eligibility
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).