Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Primary Purpose
Age-related Macular Degeneration, Geographic Atrophy
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VOY-101
Sponsored by
About this trial
This is an interventional treatment trial for Age-related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Are ≥50 years of age at the time of consent.
- Are willing and able to understand and provide written informed consent.
- Are willing and able to return for scheduled treatment and follow-up examinations.
- Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
- Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.
- Absence of signs of non-exudative MNV.
- Additional Ocular Inclusion Criteria
- Meet certain genotype criteria for risk of AMD.
Exclusion Criteria:
- Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.
- Additional Systemic, Ocular, and Genetic Exclusion Criteria.
Sites / Locations
- Retina Consultants of TexasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Low Dose
Mid Dose
High Dose
Randomized Cohort--MTD
Randomized Cohort--MTD-1
Randomized Cohort--Sham
Arm Description
VOY-101 Low Dose (single dose, IVT)
VOY-101 Mid Dose (single dose, IVT)
VOY-101 High Dose (single dose, IVT)
VOY-101 MTD (single dose, IVT)
VOY-101 Lower Dose than MTD (single dose, IVT)
Control arm (sham procedure)
Outcomes
Primary Outcome Measures
Safety Endpoints
1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])
Secondary Outcome Measures
Full Information
NCT ID
NCT05380492
First Posted
May 9, 2022
Last Updated
November 17, 2022
Sponsor
Perceive Biotherapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05380492
Brief Title
Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Official Title
Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Perceive Biotherapeutics, 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 safety study comprises a dose escalation study of VOY-101, followed by a cohort of subjects randomized to the maximum tolerated dose arm, a lower dose arm, and control arm.
Detailed Description
This is a prospective, multi-center safety phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of three dose levels of VOY-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (AMD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration, Geographic Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
The Phase 1 will enroll in a dose escalation study model (three sequential cohorts), followed by a Phase 2a cohort that will be randomized among a maximum tolerated dose arm, a lower dose arm, and a control arm.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The Phase 1 cohorts will be open-label, the Phase 2a cohort will be masked.
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
VOY-101 Low Dose (single dose, IVT)
Arm Title
Mid Dose
Arm Type
Experimental
Arm Description
VOY-101 Mid Dose (single dose, IVT)
Arm Title
High Dose
Arm Type
Experimental
Arm Description
VOY-101 High Dose (single dose, IVT)
Arm Title
Randomized Cohort--MTD
Arm Type
Active Comparator
Arm Description
VOY-101 MTD (single dose, IVT)
Arm Title
Randomized Cohort--MTD-1
Arm Type
Active Comparator
Arm Description
VOY-101 Lower Dose than MTD (single dose, IVT)
Arm Title
Randomized Cohort--Sham
Arm Type
Sham Comparator
Arm Description
Control arm (sham procedure)
Intervention Type
Biological
Intervention Name(s)
VOY-101
Intervention Description
Intravitreal injection of VOY-101
Primary Outcome Measure Information:
Title
Safety Endpoints
Description
1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])
Time Frame
Through 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are ≥50 years of age at the time of consent.
Are willing and able to understand and provide written informed consent.
Are willing and able to return for scheduled treatment and follow-up examinations.
Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.
Absence of signs of non-exudative MNV.
Additional Ocular Inclusion Criteria
Meet certain genotype criteria for risk of AMD.
Exclusion Criteria:
Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.
Additional Systemic, Ocular, and Genetic Exclusion Criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Fung, MD
Phone
14153775678
Email
annef@perceivebio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Rubin, MBA
Phone
17074778172
Email
anne@perceivebio.com
Facility Information:
Facility Name
Retina Consultants of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebbecca Taing
12. IPD Sharing Statement
Learn more about this trial
Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
We'll reach out to this number within 24 hrs