Evaluating SKG0106 for treating wet age-related macular degeneration

An Open-label, Dose-escalation Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Characteristics of SKG0106 Intraocular Solution After Single Intravitreal Injection in Chinese Patients With Neovascular (Wet) Age-related Macular Degeneration

This study is testing a new treatment called SKG0106 to see if it can help older adults with wet age-related macular degeneration who have not responded well to other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 3 sites (Beijing and 2 other locations)
• Trial ID: NCT06213038 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety and preliminary efficacy of SKG0106 in patients diagnosed with neovascular age-related macular degeneration (nAMD). Participants will be evaluated for their response to the treatment, focusing on the immunogenicity of the drug. The study will include individuals aged 50 and older who have active choroidal neovascularization (CNV) lesions and have previously responded to anti-VEGF therapy. The trial is designed to gather important data that could inform future treatment options for nAMD.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 and older with a diagnosis of nAMD and active CNV lesions who have previously responded to anti-VEGF therapy.

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

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from nAMD, potentially improving their vision and quality of life.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies targeting nAMD have shown promise in the past, indicating potential for success.

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

Beijing and 2 other locations

• Peking Union Medical College Hospital — Beijing, China (Recruiting)
• Eye & ENT Hospital of Fudan University — Shanghai, China (Recruiting)
• Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Youchen Chen — Peking Union Medical College Hospital
• Study coordinator: Youchen Chen

Conditions Neovascular Age-related Macular Degeneration; AMD; wet AMD; wAMD; nAMD