Clinical trial NCT06237777: A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diabetic Macular Edema
Keywords: DME
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Lanyue Biotech (Hangzhou) Co., Ltd.
First posted: 2024-02-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Type, severity, and incidence of ocular and systemic AEs
timeFrame: AEs: Adverse Events
measure: Incidence of DLT
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean change from baseline in BCVA
timeFrame: 48 weeks
measure: Mean change from baseline in CST
timeFrame: 48 weeks
measure: Mean change from baseline in patient-reported outcome (VFQ-25) scale score
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: Min Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: