SKG0106 for Age-Related Macular Degeneration

Recruiting at 9 trial locations

Overseen By Yongqin Wang

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Skyline Therapeutics (US) Inc.

Must be taking: Anti-VEGF

Disqualifiers: Intraocular infection, Retinal detachment, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SKG0106 for age-related macular degeneration (AMD). The goal is to determine the safety and effectiveness of SKG0106 in treating this condition. Participants receive a one-time injection in low, medium, or high doses. Those with AMD who have active eye lesions and respond well to anti-VEGF therapy (a common AMD treatment) may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that SKG0106 is likely to be safe for humans?

Research shows that SKG0106, a treatment for age-related macular degeneration, is currently undergoing safety testing in humans. Previous patients generally tolerated SKG0106 well when injected into the eye, and no serious side effects have been reported. This treatment delivers the medicine directly to the affected areas, and early studies have not shown any major negative effects. As the trial is in its early stages, researchers are carefully monitoring safety. Participants are closely observed to ensure the treatment remains safe as trials continue. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SKG0106 because it offers a unique approach to treating age-related macular degeneration (AMD). Unlike current treatments like anti-VEGF injections, which require frequent administration to slow vision loss, SKG0106 involves a one-time intraocular injection. This new delivery method could significantly reduce the treatment burden on patients. Additionally, SKG0106 targets the condition potentially more effectively by delivering a controlled dose directly to the eye, tailored in low, medium, or high doses. This could lead to better outcomes and improved quality of life for patients with AMD.

What evidence suggests that SKG0106 might be an effective treatment for age-related macular degeneration?

Research has shown that SKG0106, a new treatment for age-related macular degeneration (AMD), holds promise. Early studies found it effective in stopping the growth of unwanted blood vessels in the eye, a major issue in AMD. The treatment uses a special method to deliver medication directly to the eye, employing a harmless virus as a carrier. This approach demonstrated long-lasting effects in animal studies. Initial results suggest it could provide a lasting solution for people with neovascular AMD. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 50 or older with neovascular Age-related Macular Degeneration (nAMD). Participants must have a specific type of lesion in the eye and some fluid in the retina, with vision levels within a certain range. They cannot join if they have any active eye infections, certain types of retinal damage, recent vitreous hemorrhage, conditions that limit vision improvement, history of gene therapy or retinal detachment.

Inclusion Criteria

My previous treatment for cancer, which targeted blood vessel growth, was effective.

I can sign a consent form and follow the study's requirements.

I am 50 years old or older.

Exclusion Criteria

I have a tear in the retina of my study eye.

I have had or currently have a detached retina in my study eye.

I do not have any active eye infections or inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Phase I Treatment

Participants receive a one-time intraocular injection of SKG0106 at varying dose levels

1 day

1 visit (in-person)

Phase II Treatment

Based on Phase I results, participants receive SKG0106 in an expansion study

52 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SKG0106

Trial Overview The study tests SKG0106 intraocular solution's safety and effectiveness for nAMD patients. It starts with determining safe dosage levels (Phase I) and then expands to more patients to further assess its effects (Phase II), including how long it stays in the body and if it triggers immune responses.

How Is the Trial Designed?

Group I: Phase I: Medium dose Experimental Treatment 1 Intervention

SKG0106 One-Time Intraocular Injection Dose Level 2

Group II: Phase I: Low dose Experimental Treatment 1 Intervention

SKG0106 One-Time Intraocular Injection Dose Level 1

Group III: Phase I: High dose Experimental Treatment 1 Intervention

SKG0106 One-Time Intraocular Injection Dose Level 3

SKG0106 is already approved in United States, China for the following indications:

Approved in United States as SKG0106 for:

• Neovascular Age-related Macular Degeneration (nAMD)

Approved in China as SKG0106 for:

• Neovascular Age-related Macular Degeneration (nAMD)

Who Is Running the Clinical Trial?

Skyline Therapeutics (US) Inc.

Lead Sponsor

Trials

1

Recruited

70+

Published Research Related to This Trial

The study of 322 patients with neovascular age-related macular degeneration (AMD) showed that the duration of symptoms before treatment decreased significantly from 2008 to 2014, indicating earlier diagnosis and intervention.

Visual acuity improved over time, with patients starting treatment in 2014 showing better outcomes after one year compared to those starting in 2008, and the average number of injections required in the first year also increased, suggesting a trend towards more intensive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for neovascular age-related macular degeneration in Sweden: outcomes at seven years in the Swedish Macula Register. Westborg, I., Granstam, E., Rosso, A., et al.[2018]

In a study involving 5,781 patients over 24 months, intravitreal ranibizumab injections for treating eye conditions showed that 79.7% of patients reported no adverse events (AEs), indicating a generally favorable safety profile.

While 2,687 AEs were reported, with 30.3% classified as serious, the overall rate of AEs decreased over time, and no new safety concerns were identified, suggesting that ranibizumab is a safe option for patients under real-world conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial. Ziemssen, F., Hammer, T., Grueb, M., et al.[2022]

Only about 0.1% of the Polish population requires treatment for neovascular age-related macular degeneration (nAMD) when considering patients without severe irreversible eye damage, indicating a relatively low prevalence of this condition needing intervention.

The COVID-19 pandemic significantly impacted the enrollment in the national AMD therapeutic program, with a notable decrease in monthly enrollments, highlighting potential barriers to treatment access during health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Need for Treatment of Neovascular Age-Related Macular Degeneration: A Study Based on the Polish National Registry. Teper, SJ., Nowińska, A., Figurska, M., et al.[2022]

In a study of 1689 eyes with neovascular age-related macular degeneration (nAMD) treated with anti-VEGF, the prevalence of macular atrophy (MA) increased significantly over time, from 9.9% within 1 year to 48.4% after 9 years of treatment.

Key risk factors for developing subfoveal MA included older age, lower baseline visual acuity, and the frequency of inactive lesion grading, suggesting that monitoring these factors could help manage the risk of MA in patients undergoing anti-VEGF therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and characteristics of macular atrophy in eyes with neovascular age-related macular degeneration. A study from a long-term observational dataset: the Fight Retinal Blindness! project. Daien, V., Nguyen, V., Essex, RW., et al.[2021]

Intravitreal injections of antivascular endothelial growth factor (VEGF) drugs, such as pegaptanib and ranibizumab, are generally safe and effective treatments for neovascular age-related macular degeneration (AMD) for up to 2-3 years, based on current literature.

While pegaptanib and ranibizumab have strong evidence supporting their efficacy, the evidence for bevacizumab is not as robust, indicating a need for further research on its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intravitreal anti-VEGF injections for age-related macular degeneration. Jeganathan, VS., Verma, N.[2022]

Citations

1. 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06213038

NCT06213038 | A Clinical Study Evaluating the Safety and ... This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD. Official Title. An Open-label, Dose- ...

3. 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 ...

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

AMD Gene Therapy Cleared for US Trial In preclinical studies, the therapy has demonstrated efficacy in inhibiting intraocular neovascularization with long-lasting durability and a ...

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

SKG0106, an AAV vector delivered intravitreally, for effective ... SKG0106 is a novel recombinant AAV vector developed by Skyline Therapeutics for the treatment of neovascular age-related macular degeneration (nAMD) via ...

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

NCT05986864 | Phase I/II Study of SKG0106 Intravitreal ... Phase I/​II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD). ClinicalTrials.gov ID NCT05986864.

7. withpower.com withpower.com/trial/phase-2-macular-degeneration-2-2023-2c24e?condition=&query=SKG0106&overallStatus=Recruiting&hasNoPlacebo=false

SKG0106 for Age-Related Macular Degeneration What safety data exists for SKG0106 in treating age-related macular degeneration? The available research discusses the safety of anti-VEGF (vascular endothelial ...