Recruiting
Phase 1
Phase 2

SKG0106

Sponsor:

Skyline Therapeutics (US) Inc.

Code:

NCT05986864

Conditions

Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

SKG0106

Study Details

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.

Conditions

Neovascular Age-related Macular Degeneration

Study ID

NCT05986864

Start date

Feb 23, 2024

Status verified date

Aug, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I: Low dose

SKG0106 One-Time Intraocular Injection Dose Level 1

experimental: Phase I: Medium dose

SKG0106 One-Time Intraocular Injection Dose Level 2

experimental: Phase I: High dose

SKG0106 One-Time Intraocular Injection Dose Level 3

Interventions

SKG0106

SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product

Primary outcome measure

  • Characteristics of dose limiting toxicities (DLTs) [ Time Frame: 4 Weeks ]
  • Type, severity, and incidence of ocular and systemic adverse events (AEs) [ Time Frame: 52 Weeks ]

Central Contacts and Locations

Central contacts

Locations

Ophthalmic Consultants of Boston

Recruiting

Boston, Massachusetts, United States, 02114

Retina Consultants of Texas

Recruiting

Katy, Texas, United States, 77494

Principal Investigator:

Charles C Wykoff, MD

Wagner Kapoor Research Institute

Recruiting

Norfolk, Virginia, United States, 23502

Principal Investigator:

Alan Wagner, MD

More Information

Sponsor

Skyline Therapeutics (US) Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • AMD
  • wet AMD
  • wAMD
  • nAMD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Skyline Therapeutics (US) Inc. on 2026-08-28.