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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237777
• Other study ID #: SKG0106-002
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Eye & ENT Hospital of Fudan University
• Contact: Min Wang, Doctor
• Phone: +86 13816630287
• Email: ykmarkwang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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).

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Eye & ENT Hospital of Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Wang Min	Lanyue Biotech (Hangzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, severity, and incidence of ocular and systemic AEs	48 weeks	AEs: Adverse Events
Primary	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	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
Secondary	Mean change from baseline in CST	CST (Central Subfield Thickness) is measured by Spectral domain optical coherence tomography (SD-OCT).	48 weeks
Secondary	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