SKG0106 for Age-Related Macular Degeneration

Recruiting at 9 trial locations

Overseen By Yongqin Wang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Skyline Therapeutics

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

83 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term safety and effectiveness of SKG0106, an experimental treatment for neovascular (wet) age-related macular degeneration (nAMD), a severe eye condition that can lead to vision loss. The trial will assess individuals from earlier studies involving SKG0106 to evaluate their progress up to five years after treatment. Candidates for this study include those who previously received SKG0106 in those trials and are willing to continue with follow-up visits. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients, offering valuable insights for those continuing their journey with SKG0106.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for SKG0106?

Previous studies have shown promising safety results for SKG0106. Research indicates that SKG0106 is a gene therapy using a harmless virus to deliver treatment. These studies have not reported any major safety issues. Initial trials focused on its safety and found it well-tolerated by patients, with no severe side effects linked to the treatment.

Additionally, preclinical tests supported its safety and effectiveness for treating neovascular age-related macular degeneration (nAMD). While SKG0106 remains under study, earlier research suggests it is generally safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SKG0106 for the treatment of nAMD (neovascular age-related macular degeneration) because it offers a potentially new approach compared to existing treatments like anti-VEGF injections. Unlike current therapies that primarily inhibit vascular endothelial growth factor to prevent vision loss, SKG0106 may target different pathways or mechanisms involved in the disease. This could lead to improved outcomes or benefits for patients who do not respond well to current options. Additionally, the long-term follow-up aspect of the study aims to evaluate the sustained effects of SKG0106, which could provide insights into its durability and long-term safety for managing nAMD.

What evidence suggests that SKG0106 might be an effective treatment for nAMD?

Research has shown that SKG0106, a treatment delivered directly into the eye, offers promising results for treating wet age-related macular degeneration (nAMD). In earlier studies, SKG0106 matched the effectiveness of Eylea®, a well-known treatment, at 6 and 13 weeks post-administration. It also demonstrated strong results in longer-term follow-ups, suggesting lasting benefits. This treatment works by slowing or stopping the growth of abnormal blood vessels that damage vision in nAMD. These findings provide strong evidence of its potential effectiveness in managing nAMD. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

I agree to sign the consent form and follow the study rules.

I have received the SKG0106 injection in a previous study for nAMD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Long-term Follow-up

Participants undergo safety and efficacy assessments up to 5 years post study drug injection

5 years

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SKG0106

How Is the Trial Designed?

Group I: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3 Experimental Treatment 1 Intervention

No investigational product will be administered in this study.

Group II: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2 Experimental Treatment 1 Intervention

No investigational product will be administered in this study.

Group III: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1 Experimental Treatment 1 Intervention

No investigational product will be administered in this study.

Who Is Running the Clinical Trial?

Skyline Therapeutics

Lead Sponsor

Trials

1

Recruited

80+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06346600

A Long-term Follow-up Study to Evaluate SKG0106 in the ... Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection. What is the study measuring?

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06346600/a-long-term-follow-up-study-to-evaluate-skg0106-in-the-treatment-of-patients-with-namd

A Long-term Follow-up Study to Evaluate SKG0106 in ... This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with ...

3. delta.larvol.com delta.larvol.com/Products/?ProductId=3b2204df-f69d-4826-a52b-ce0a92e59995

SKG0106 / Skyline Therap Delicious. April 05, 2024. A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD (clinicaltrials.gov) - P=N/A | N=83 ...

4. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2799427

SKG0106, an AAV vector delivered intravitreally, for effective ... SKG0106 exhibited comparable efficacy to that of Eylea® at 6, and 13 wks following treatment. SKG0106 showed strong efficacy in the 26-wks groups, in contrast, ...

5. scge.mcw.edu scge.mcw.edu/platform/data/clinicalTrials/report/NCT05986864

Phase I/II Study of SKG0106 Intravitreal Injection ... This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05986864

NCT05986864 | Phase I/II Study of SKG0106 Intravitreal ... This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects ...

7. skytx.com skytx.com/news-2023_07_03

Skyline Therapeutics Receives FDA Clearance of IND ... Robust preclinical proof-of-concept studies validated SKG0106 as a safe and effective anti-angiogenic treatment with durable suppression of ...

8. cgtlive.com cgtlive.com/view/amd-gene-therapy-cleared-for-us-trial

AMD Gene Therapy Cleared for US Trial The FDA has granted investigational new drug (IND) application clearance to Skyline Therapeutics' gene therapy SKG0106 for the treatment of ...