A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients

An Open, Dose-escalation Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients in China

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

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.

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).