A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients
NCT ID: NCT06237777
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2024-05-31
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose-escalation
SKG0106 one-time deliver
SKG0106 intravitreal injection dose level 1, 2 or 3
SKG0106 is a recombinant adeno-associated virus (rAAV) vector-based in vivo gene therapeutic product.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Lanyue Biotech (Hangzhou) Co., Ltd.
INDUSTRY
Wang Min
OTHER
Responsible Party
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Wang Min
Chief physician
Principal Investigators
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Min Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Eye & ENT Hospital of Fudan University
Locations
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Peking Union Medical College Hospital
Beijing, , China
Eye & ENT Hospital of Fudan University
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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SKG0106-002
Identifier Type: -
Identifier Source: org_study_id
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