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

NCT06237777 | Recruiting Phase 1 DMC

• 1 other identifier: SKG0106-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Macular Edema

Keywords

DME

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mean change from baseline in BCVA

  48 weeks

• Mean change from baseline in CST

  48 weeks

• Mean change from baseline in patient-reported outcome (VFQ-25) scale score

  48 weeks

Study Arms (1)

Dose-escalation

EXPERIMENTAL

SKG0106 one-time deliver

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

Interventions

SKG0106 intravitreal injection dose level 1, 2 or 3 GENETIC

SKG0106 is a recombinant adeno-associated virus (rAAV) vector-based in vivo gene therapeutic product.

Also known as: SKG0106

Dose-escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wang Min: lead
• Lanyue Biotech (Hangzhou) Co., Ltd.: collaborator

Study Sites (2)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, China

RECRUITING

Study Officials

• Min Wang, Doctor

  Eye & ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Wang, Doctor

CONTACT

+86 13816630287; ykmarkwang@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 1, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CN (2)