SKG0106 for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Skyline Therapeutics (US) Inc.

Must be taking: Anti-VEGF

Disqualifiers: Intraocular infection, Retinal detachment, others

No Placebo Group

Approved in 2 Jurisdictions

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.

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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.

Trial 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)

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ophthalmic Consultants of Boston Boston, MA

Retina Vitreous Associates of Florida - Saint Petersburg Saint Petersburg, FL

Retina Consultants of Texas Katy, TX

Wagner Kapoor Research Institute Norfolk, VA

Who Is Running the Clinical Trial?

Skyline Therapeutics (US) Inc. Lead Sponsor

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] To present Swedish Macula Register (SMR) data regarding treatment of neovascular age-related macular degeneration (AMD) in clinical practice since 2008.

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] To assess the prevalence and characteristics associated with macular atrophy (MA) in eyes with neovascular age-related macular degeneration (nAMD) treated with vascular endothelial growth factor (VEGF) inhibitors.

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

Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial. [2022] The prospective, noninterventional OCEAN study assessed the safety of intravitreal ranibizumab injections for treatment of neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion under real-world conditions in Germany.

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] The Polish National AMD Therapeutic Program offered us a unique opportunity to determine the need for treatment of neovascular age-related macular degeneration (nAMD).

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

Safety and efficacy of intravitreal anti-VEGF injections for age-related macular degeneration. [2022] To report the safety and efficacy of intravitreal injections for age-related macular degeneration (AMD).