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

Phase 1

Recruiting

• Conditions: Diabetic Macular Edema
• Interventions: Genetic: SKG0106 intravitreal injection dose level 1, 2 or 3

• Registration Number: NCT06237777
• Lead Sponsor: Wang Min

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.

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30
• Study Start: 2024-05
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose-escalation	SKG0106 intravitreal injection dose level 1, 2 or 3	SKG0106 one-time deliver

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, China