SKG0106 for Age-Related Macular Degeneration

Recruiting at 8 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

Trial Summary

What is the purpose of this trial?

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.

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.

What safety data exists for SKG0106 in treating age-related macular degeneration?

The available research discusses the safety of anti-VEGF (vascular endothelial growth factor) treatments, which are commonly used for age-related macular degeneration, but does not specifically mention SKG0106. Therefore, no specific safety data for SKG0106 is provided in the available studies. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment for neovascular age-related macular degeneration in Sweden: outcomes at seven years in the Swedish Macula Register. [2018]

2. England 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The Need for Treatment of Neovascular Age-Related Macular Degeneration: A Study Based on the Polish National Registry. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intravitreal anti-VEGF injections for age-related macular degeneration. [2022]