Recruiting NCT06213038
A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SKG0106.
- Who it may be relevant to
- Registry conditions: Neovascular Age-related Macular Degeneration. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open-label, Dose-escalation Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Characteristics of SKG0106 Intraocular Solution After Single Intravitreal Injection in Chinese Patients With Neovascular (Wet) Age-related Macular Degeneration
Overview
This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.
Interventions
- Genetic SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Primary outcome measures
- Characteristics of dose limiting toxicities (DLTs) [Time frame: 4 weeks]
- Type, severity, and incidence of ocular and systemic adverse events (AEs) [Time frame: 48 weeks]
Secondary outcome measures (3)
- Mean change from baseline in best corrected visual acuity (BCVA) at each visit BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at screening and baseline. [Time frame: 24 weeks]
- Mean change from baseline in central subfield thickness (CST) at each visit Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at screening and at each visit (prior to study drug injection, if available). [Time frame: 24 weeks]
- Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome. [Time frame: 48 weeks]
Eligibility criteria
Inclusion criteria
- Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;
- Aged ≥ 50 years at screening;
Study Eye:
- Diagnosis of nAMD as determined by the PI;
- Active CNV lesions secondary to age-related macular degeneration (AMD);
- Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment
Exclusion criteria
- Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;
- Retinal pigment epithelial tear in the study eye at screening;
- Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
- Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
- History of retinal detachment or active retinal detachment in the study eye;
- Any prior gene therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Peking Union Medical College Hospital — Beijing
- Eye & ENT Hospital of Fudan University — Shanghai
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hos — Shanghai
Identifiers
NCT: NCT06213038 · SKG0106-001