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RecruitingPhase 1/Phase 2

Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Skyline Therapeutics (US) Inc. · NCT05986864

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
68
US sites recruiting
3
Study start
February 23, 2024
Record last updated
August 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SKG0106

Conditions: Neovascular Age-related Macular Degeneration

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion criteria

  • 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;
  • Aged ≥ 50 years at screening;

Study Eye

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

Exclusion Criteria

  • 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;
  • Retinal pigment epithelial tear in the study eye at screening;
  • Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
  • Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
  • History of retinal detachment or active retinal detachment in the study eye;
  • Any prior gene therapy.

Recruiting US locations

  • Ophthalmic Consultants of Boston

    Boston, MA 02114

  • Retina Consultants of Texas

    Katy, TX 77494

    Site contact: Marie Chin

  • Wagner Kapoor Research Institute

    Norfolk, VA 23502

    Site contact: Chris Riebling

Study contacts (from the official record)

  • Eddy Anglade, MD · +1-908-884-1246 · eanglade@focusbiosciences.com
All phase 1 studies in Massachusetts →
Phase I/II Study of SKG0106 Intravitreal Injection in Patients… (NCT05986864) | Bored Studies