Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Skyline Therapeutics (US) Inc. · NCT05986864
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
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