Clinical trial NCT05986864: Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Official title: Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: AMD
wet AMD
wAMD
nAMD
Lead sponsor: Skyline Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Characteristics of dose limiting toxicities (DLTs)
timeFrame: 4 Weeks
measure: Type, severity, and incidence of ocular and systemic adverse events (AEs)
timeFrame: 52 Weeks
Secondary outcomes:
measure: Mean change from baseline in best corrected visual acuity (BCVA) at each visit
timeFrame: 52 Weeks
measure: Mean change from baseline in central subfield thickness (CST) at each visit
timeFrame: 52 Weeks
measure: Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida - Saint Petersburg
state: Florida
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Norfolk
country: United States
facility: Wagner Kapoor Research Institute
state: Virginia
city: Hefei
country: China
facility: The Second Hospital Of Anhui Medical University
state: Anhui
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Eye Hospital, WMU (Zhejiang Eye Hospital)
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: