NCT05986864 Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
| NCT ID | NCT05986864 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Skyline Therapeutics (US) Inc. |
| Condition | Neovascular Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-02-23 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 68 participants in total. It began in 2024-02-23 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05986864 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Neovascular Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05986864 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05986864 currently recruiting?
Yes, NCT05986864 is actively recruiting participants. Contact the research team at yongqin.wang@skytx.com for enrollment information.
Where is the NCT05986864 trial being conducted?
This trial is being conducted at St. Petersburg, United States, Boston, United States, Katy, United States, Norfolk, United States and 5 additional locations.
Who is sponsoring the NCT05986864 clinical trial?
NCT05986864 is sponsored by Skyline Therapeutics (US) Inc.. The trial plans to enroll 68 participants.