Neovascular Age-related Macular DegenerationPhase 1NCT06213038
A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
A Phase 1 study testing SKG0106 in people with Neovascular Age-related Macular Degeneration, run by Youxin Chen at 3 sites in China.
Trial summary
This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- SKG0106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesChina
- Study dates
- 5 May 2023to 21 Nov 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
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 Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
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
This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.
- Being tested
- SKG0106
- Keywords
- AMD, wet AMD, wAMD, nAMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKG0106Genetic
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 1 Receives: Genetic: SKG0106 |
| Dose Level 2 | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 2 Receives: Genetic: SKG0106 |
| Dose Level 3 | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 3 Receives: Genetic: SKG0106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of dose limiting toxicities (DLTs)
Measured: 4 weeks
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Measured: 48 weeks
Secondary outcomes (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.
Measured: 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).
Measured: 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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start5 May 2023
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Youxin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Youxin Chen, Peking Union Medical College Hospital
- Investigators
- Youchen Chen, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213038
- Sponsor's protocol ID
- SKG0106-001
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No