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

Wang Min

Status and phase

Enrolling

Phase 1

Conditions

Diabetic Macular Edema

Treatments

Genetic: SKG0106 intravitreal injection dose level 1, 2 or 3

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06237777

SKG0106-002

Details and patient eligibility

About

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

Full 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.

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).