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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Genetic: SKG0106 intravitreal injection dose level 1, 2 or 3

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 Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Min Wang, Doctor; Phone Number: +86 13816630287; Email: ykmarkwang@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Eye & ENT Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose-escalation; SKG0106 one-time deliver	Genetic: SKG0106 intravitreal injection dose level 1, 2 or 3; SKG0106 is a recombinant adeno-associated virus (rAAV) vector-based in vivo gene therapeutic product.; Other Names: SKG0106

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type, severity, and incidence of ocular and systemic AEs	48 weeks	AEs: Adverse Events
Incidence of DLT	DLT (Dose-limiting Toxicity) is judged by assessing the following AEs such as: Severe visual acuity decline; Endoophthalmitis by investigator; Vitreous hemorrhage by investigator	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in BCVA	BCVA (Best Corrected Visual Acuity) of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing.	48 weeks
Mean change from baseline in CST	CST (Central Subfield Thickness) is measured by Spectral domain optical coherence tomography (SD-OCT).	48 weeks
Mean change from baseline in patient-reported outcome (VFQ-25) scale score	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.	48 weeks

Collaborators and Investigators

• Sponsor: Wang Min
• Collaborators: Lanyue Biotech (Hangzhou) Co., Ltd.
• Investigators: Principal Investigator: Min Wang, Doctor, Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: DME
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: SKG0106-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No