Injection of SKG0106 for treating wet age-related macular degeneration

Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

This study is testing a new injection called SKG0106 to see if it can safely help people with wet age-related macular degeneration improve their vision.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Skyline Therapeutics (industry)
• Locations: 9 sites (St. Petersburg, Florida and 8 other locations)
• Trial ID: NCT05986864 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and preliminary effectiveness of SKG0106, an intravitreal injection, in patients with neovascular age-related macular degeneration (nAMD). It consists of a Phase I dose escalation study followed by a Phase II expansion study based on initial results. Participants will be monitored for immunogenicity and pharmacokinetic characteristics of the treatment. The study aims to provide insights into the potential benefits of SKG0106 for patients suffering from this condition.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with a diagnosis of nAMD who have responded to anti-VEGF therapy.

Not a fit: Patients with active intraocular infections, retinal pigment epithelial tears, or other conditions that limit visual acuity improvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve vision and quality of life for patients with neovascular age-related macular degeneration.

How similar studies have performed: Other studies have shown promise with similar approaches in treating nAMD, but the specific use of SKG0106 is novel.

Eligibility criteria

Inclusion criteria:

1. Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;
2. Aged ≥ 50 years at screening;

   Study Eye:
3. Diagnosis of nAMD as determined by the PI;
4. Active CNV lesions secondary to age-related macular degeneration (AMD);
5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment.

Exclusion Criteria:

1. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;
2. Retinal pigment epithelial tear in the study eye at screening;
3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
5. History of retinal detachment or active retinal detachment in the study eye;
6. Any prior gene therapy.

Where this trial is running

St. Petersburg, Florida and 8 other locations

• Retina Vitreous Associates of Florida - Saint Petersburg — St. Petersburg, Florida, United States (NOT_YET_RECRUITING)
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States (RECRUITING)
• Retina Consultants of Texas — Katy, Texas, United States (RECRUITING)
• Wagner Kapoor Research Institute — Norfolk, Virginia, United States (RECRUITING)
• The Second Hospital Of Anhui Medical University — Hefei, Anhui, China (RECRUITING)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (RECRUITING)
• Eye Hospital, WMU (Zhejiang Eye Hospital) — Wenzhou, Zhejiang, China (RECRUITING)
• Beijing Hospital — Beijing, China (RECRUITING)
• Peking Union Medical College Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yongqin Wang

Conditions: Neovascular Age-related Macular Degeneration, AMD, wet AMD, wAMD, nAMD