Phase I/II Study of SKG0106 Intravitreal Injection 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
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Overview
This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.
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: 52 Weeks]
Secondary outcome measures (3)
- Mean change from baseline in best corrected visual acuity (BCVA) at each visit [Time frame: 52 Weeks]
- Mean change from baseline in central subfield thickness (CST) at each visit [Time frame: 52 Weeks]
- Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit [Time frame: 52 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 · 5 centers
- The Second Hospital Of Anhui Medical University — Hefei
- Zhejiang Provincial People's Hospital — Hangzhou
- Eye Hospital, WMU (Zhejiang Eye Hospital) — Wenzhou
- Beijing Hospital — Beijing
- Peking Union Medical College Hospital — Beijing
United States · 4 centers
- Retina Vitreous Associates of Florida - Saint Petersburg — St. Petersburg
- Ophthalmic Consultants of Boston — Boston
- Retina Consultants of Texas — Katy
- Wagner Kapoor Research Institute — Norfolk
Identifiers
NCT: NCT05986864 · SKG0106-101