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

Skyline Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Genetic: SKG0106

Study type: Interventional

Funder types: Industry

Identifiers

NCT05986864

SKG0106-101

Details and patient eligibility

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

Phase I: Low dose

Experimental group

Description:

SKG0106 One-Time Intraocular Injection Dose Level 1

Treatment:

Genetic: SKG0106

Phase I: Medium dose

Experimental group

Description:

SKG0106 One-Time Intraocular Injection Dose Level 2

Treatment:

Genetic: SKG0106

Phase I: High dose

Experimental group

Description:

SKG0106 One-Time Intraocular Injection Dose Level 3

Treatment:

Genetic: SKG0106