Back to resultsVOY-101 in Advanced Non-Neovascular Age-Related Macular Degeneration
Primary Purpose
Age-Related Macular Degeneration
Status
Recruiting
Phase
Phase 1
Locations
International
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 for study eye. 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
- Sydney Retina Clinic and Day Surgery
- Centre for Eye Research Australia (CERA)
- Cabrini Research
- Tel-Aviv Sourasky Medical Center, Ophthalmology DivisionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: Low Dose
Experimental: High Dose
Arm Description
VOY-101 Low Dose (single dose, IVT)
VOY-101 High Dose (single dose, IVT)
Outcomes
Primary Outcome Measures
Safety Endpoints and tolerability
Evaluation of safety and tolerability on ocular and systemic assessments
Secondary Outcome Measures
Change from baseline in laboratory assessments
Evaluation of laboratory measures from baseline through study termination
Change from baseline in markers of inflammation
Evaluation of markers of inflammation from baseline through study termination
Full Information
NCT ID
NCT06087458
First Posted
October 12, 2023
Last Updated
October 17, 2023
Sponsor
Perceive Biotherapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06087458
Brief Title
VOY-101 in Advanced Non-Neovascular Age-Related Macular Degeneration
Official Title
VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2027 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Phase 1 safety study of VOY-101 comprises a two dose Cohort escalation, followed by a Phase 2a.
Detailed Description
This is a prospective, open-label, multi-center Phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of two dose levels of VOY-101 therapy in subjects with advanced 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Phase 1 will enroll in a dose escalation study model (two sequential cohorts), followed by a Phase 2a cohort that will be randomized among two arms.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Low Dose
Arm Type
Experimental
Arm Description
VOY-101 Low Dose (single dose, IVT)
Arm Title
Experimental: High Dose
Arm Type
Experimental
Arm Description
VOY-101 High Dose (single dose, IVT)
Intervention Type
Biological
Intervention Name(s)
VOY-101
Intervention Description
VOY-101
Primary Outcome Measure Information:
Title
Safety Endpoints and tolerability
Description
Evaluation of safety and tolerability on ocular and systemic assessments
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change from baseline in laboratory assessments
Description
Evaluation of laboratory measures from baseline through study termination
Time Frame
24 months
Title
Change from baseline in markers of inflammation
Description
Evaluation of markers of inflammation from baseline through study termination
Time Frame
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 for study eye.
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
Phone
4153775678
Email
annef@perceivebio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Rubin
Phone
17074778172
Email
anne@perceivebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Fung, MD
Organizational Affiliation
Perceive Biotherapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sydney Retina Clinic and Day Surgery
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Hong
Facility Name
Centre for Eye Research Australia (CERA)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marios Constantinou
Facility Name
Cabrini Research
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cleopatra McIntosh
Facility Name
Tel-Aviv Sourasky Medical Center, Ophthalmology Division
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adi Riza
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VOY-101 in Advanced Non-Neovascular Age-Related Macular Degeneration
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