Back to resultsPhase I/II Study of SKG0106 Intraocular Solution in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Primary Purpose
Neovascular Age-related Macular Degeneration
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SKG0106
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring AMD, wet AMD, wAMD, nAMD
Eligibility 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.
Sites / Locations
- Retina Consultants of Texas
- Wagner Kapoor Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Phase I: Low dose
Phase I: Medium dose
Phase I: High dose
Arm Description
SKG0106 One-Time Intraocular Injection Dose Level 1
SKG0106 One-Time Intraocular Injection Dose Level 2
SKG0106 One-Time Intraocular Injection Dose Level 3
Outcomes
Primary Outcome Measures
Characteristics of dose limiting toxicities (DLTs)
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Secondary Outcome Measures
Mean change from baseline in best corrected visual acuity (BCVA) at each visit
BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at screening and baseline.
Mean change from baseline in central subfield thickness (CST) at each visit
Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at screening and at each visit (prior to study drug injection, if available).
Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit
Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome.
Full Information
NCT ID
NCT05986864
First Posted
August 3, 2023
Last Updated
September 25, 2023
Sponsor
Skyline Therapeutics (US) Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05986864
Brief Title
Phase I/II Study of SKG0106 Intraocular Solution in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Official Title
A Multicenter, Open-label, Dose Escalation, Phase 1 Clinical Study and Randomized, Double-masked, Controlled, Dose Expansion Phase 2 Clinical Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity, and Pharmacokinetics of SKG0106 Intraocular Solution in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
September 30, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skyline Therapeutics (US) Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
AMD, wet AMD, wAMD, nAMD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase I: Low dose
Arm Type
Experimental
Arm Description
SKG0106 One-Time Intraocular Injection Dose Level 1
Arm Title
Phase I: Medium dose
Arm Type
Experimental
Arm Description
SKG0106 One-Time Intraocular Injection Dose Level 2
Arm Title
Phase I: High dose
Arm Type
Experimental
Arm Description
SKG0106 One-Time Intraocular Injection Dose Level 3
Intervention Type
Genetic
Intervention Name(s)
SKG0106
Intervention Description
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Primary Outcome Measure Information:
Title
Characteristics of dose limiting toxicities (DLTs)
Time Frame
4 Weeks
Title
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline in best corrected visual acuity (BCVA) at each visit
Description
BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at screening and baseline.
Time Frame
52 Weeks
Title
Mean change from baseline in central subfield thickness (CST) at each visit
Description
Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at screening and at each visit (prior to study drug injection, if available).
Time Frame
52 Weeks
Title
Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit
Description
Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome.
Time Frame
52 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongqin Wang
Phone
+86 18616737445
Email
yongqin.wang@skytx.com
Facility Information:
Facility Name
Retina Consultants of Texas
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Chin
First Name & Middle Initial & Last Name & Degree
Charles C Wykoff, MD
Facility Name
Wagner Kapoor Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Riebling
First Name & Middle Initial & Last Name & Degree
Alan Wagner, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase I/II Study of SKG0106 Intraocular Solution in Patients With Neovascular Age-related Macular Degeneration (nAMD)
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