Injection of SKG0106 for treating wet age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Eddy Anglade, MD
• Email: eanglade@focusbiosciences.com
• Phone: +1-908-884-1246

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ABP 938 8 mg vs EYLEA® HD (aflibercept) in neovascular AMD

  This trial tests whether ABP 938 8 mg works as well as aflibercept 8 mg in people with neovascular AMD.

  Recruiting at 81 sites Phase 3 Amgen · Fullerton, California and 80 other locations · NCT07614776

• PRL3-zumab for neovascular (wet) age-related macular degeneration

  This trial tests whether three intravenous doses of PRL3-zumab given every two weeks can help people with neovascular (wet) age-related macular degeneration who have not responded to at least two standard intravitreal treatments.

  Recruiting Phase 1/2 Intra-IMMUSG Pte Ltd · Singapore · NCT07547228

• IBI302 treatment for neovascular age-related macular degeneration

  This trial will try intravitreal 8 mg IBI302 injections to see if they help people aged 50 and older with active neovascular (wet) AMD.

  Recruiting Phase 2 Innovent Biologics Technology Limited (Shanghai R&D Center) · Shanghai, Shanghai Municipality · NCT07275840

• LX111 gene therapy for neovascular (wet) age-related macular degeneration

  This will test a single eye injection of LX111 gene therapy in people 50 and older with active wet AMD to see if it is safe and helps maintain or improve vision.

  Recruiting Early Phase 1 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07053358

• Surabgene Lomparvovec to reduce injections and preserve vision in adults with wet AMD

  This study will test whether a single subretinal dose of Surabgene Lomparvovec can reduce the need for repeated eye injections and help preserve vision in adults 50 and older with previously treated neovascular (wet) AMD compared with standard ranibizumab care.

  Recruiting at 138 sites Phase 3 AbbVie · Mesa, Arizona and 137 other locations · NCT07007065

• Effects of Faricimab on kidney function in diabetic patients

  This study is testing if a new eye injection called Faricimab can help improve kidney function in people with diabetes compared to a standard treatment.

  Recruiting University Hospital, Alexandroupolis · Alexandroupoli, Evros and 1 other locations · NCT06929507

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.