Neovascular Age-related Macular DegenerationPhase 1/2NCT05986864
Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
A Phase 1/2 study testing SKG0106 in people with Neovascular Age-related Macular Degeneration, run by Skyline Therapeutics (US) Inc. at 9 sites in 2 countries.
Trial summary
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. 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
- 68 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 23 Feb 2024to 30 Jan 2027
- Phase
- Phase 1/2
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
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
China5 sites, 5 recruiting
- Recruiting
Beijing Hospital
Beijing
- Recruiting
Peking Union Medical College Hospital
Beijing
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
- Recruiting
The Second Hospital Of Anhui Medical University
Hefei, Anhui
- Recruiting
Eye Hospital, WMU (Zhejiang Eye Hospital)
Wenzhou, Zhejiang
United States4 sites, 4 recruiting
- Recruiting
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
- Recruiting
Retina Consultants of Texas
Katy, Texas, 77494
Marie Chin
Charles C Wykoff, MD
- Recruiting
Wagner Kapoor Research Institute
Norfolk, Virginia, 23502
Chris Riebling
Alan Wagner, MD
- Not yet recruiting
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, 33711
About this study
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)
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.
- 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 |
|---|---|---|
| Phase I: Low dose | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 1 Receives: Genetic: SKG0106 |
| Phase I: Medium dose | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 2 Receives: Genetic: SKG0106 |
| Phase I: High dose | 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: 52 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: 52 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: 52 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: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start23 Feb 2024
- Primary completionJan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skyline Therapeutics (US) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986864
- Sponsor's protocol ID
- SKG0106-101
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No