Neovascular (Wet) Age-related Macular DegenerationNCT06346600
A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD
An observational study of Neovascular (Wet) Age-related Macular Degeneration, run by Skyline Therapeutics at 10 sites in 2 countries.
Trial summary
This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular (Wet) Age-related Macular Degeneration
- What is being tested?
- SKG0106
- Type of treatment
- Injection or infusion
- How many people
- 83 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 2 Apr 2025to Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: It is expected that a total of 83 study subjects from parent study will be enrolled. Subjects who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.
Who may be able to join
- Subjects who only meet all of the following criteria are eligible for this study:
- nAMD subjects who have been enrolled in the SKG0106-related study and received SKG0106 injection;
- Subjects who voluntarily sign an informed consent form (ICF) and comply with the protocol to complete the study
Who cannot join
- Subjects who are judged by the investigator unsuitable for this study
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
China7 sites, 7 recruiting
- Not yet recruiting
Beijing Hospital
Beijing
- Recruiting
Peking Union Medical College Hospital
Beijing
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
- Not yet recruiting
The Second Hospital Of Anhui Medical University
Hefei, Anhui
- Recruiting
EYE & ENT Hospital of Fudan University
Shanghai
- Not yet recruiting
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai
- Not yet recruiting
Eye Hospital, WMU (Zhejiang Eye Hospital)
Wenzhou, Zhejiang
United States3 sites, 3 recruiting
- Not yet recruiting
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
- Not yet recruiting
Retina Consultants of Texas
Katy, Texas, 77494
- Not yet recruiting
Wagner Macula & Retina Center
Norfolk, Virginia, 23502
About this study
Official title: A Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With Neovascular (Wet) Age-related Macular Degeneration (nAMD)
This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection.
- Being tested
- SKG0106
- Keywords
- nAMD, wAMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKG0106Genetic
Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection.
| Study group | Role | What they receive |
|---|---|---|
| Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1 | No investigational product will be administered in this study. Receives: Genetic: SKG0106 | |
| Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2 | No investigational product will be administered in this study. Receives: Genetic: SKG0106 | |
| Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3 | No investigational product will be administered in this study. Receives: Genetic: SKG0106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Measured: 5 years post study drug injection
Secondary outcomes (3)
Mean change in best corrected visual acuity (BCVA) at each visit from baseline
BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at each visit.
Measured: 5 years post study drug injection
Mean change in macular central subfield thickness (CST) at each visit from baseline
Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at each visit.
Measured: 5 years post study drug injection
Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline
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: 5 years post study drug injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start2 Apr 2025
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular (Wet) 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skyline Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346600
- Sponsor's protocol ID
- SKG0106-LF
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With Neovascular (Wet) Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT06346600
- Acronym / sponsor ID
- SKG0106-LF
- Keywords
- nAMD, wAMD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Skyline TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1 | – | Genetic: SKG0106No investigational product will be administered in this study. |
| Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2 | – | Genetic: SKG0106No investigational product will be administered in this study. |
| Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3 | – | Genetic: SKG0106No investigational product will be administered in this study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is expected that a total of 83 study subjects from parent study will be enrolled. Subjects who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.
Key inclusion criteria (3 listed)
- nAMD subjects who have been enrolled in the SKG0106-related study and received SKG0106 injection;
- Subjects who voluntarily sign an informed consent form (ICF) and comply with the protocol to complete the study
Key exclusion criteria (1 listed)
- Subjects who are judged by the investigator unsuitable for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKG0106Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection. | Genetic | Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1, Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2, Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3 |
Primary outcome
Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Time frame: 5 years post study drug injection
3 secondary outcomes
Mean change in best corrected visual acuity (BCVA) at each visit from baseline
Time frame: 5 years post study drug injection
Mean change in macular central subfield thickness (CST) at each visit from baseline
Time frame: 5 years post study drug injection
Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline
Time frame: 5 years post study drug injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular (Wet) Age-related Macular Degeneration, run by Skyline Therapeutics at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eddy Anglade, MD (+1-908-884-1246, eanglade@focusbiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (time frame: 5 years post study drug injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026; AzTrials last refreshed its copy on 5 Nov 2026.