Age-related Macular DegenerationPhase 1/2NCT05380492
Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
A Phase 1/2 study testing VOY-101 in people with Age-related Macular Degeneration and Geographic Atrophy, run by Perceive Biotherapeutics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Geographic Atrophy
- What is being tested?
- VOY-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Nov 2022to Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Retina Consultants of Texas
Bellaire, Texas, 77401
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
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.
Read the 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).
- Being tested
- VOY-101
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOY-101Biological
Intravitreal injection of VOY-101
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | VOY-101 Low Dose (single dose, IVT) Receives: Biological: VOY-101 |
| Mid Dose | Experimental | VOY-101 Mid Dose (single dose, IVT) Receives: Biological: VOY-101 |
| High Dose | Experimental | VOY-101 High Dose (single dose, IVT) Receives: Biological: VOY-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoints
- Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])
Measured: Through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start17 Nov 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perceive Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380492
- Sponsor's protocol ID
- PBI-AMD-001
- Status last verified
- Apr 2024
- First submitted
- 9 May 2022
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05380492
- Acronym / sponsor ID
- PBI-AMD-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Perceive Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Biological: VOY-101VOY-101 Low Dose (single dose, IVT) |
| Mid Dose | Experimental | Biological: VOY-101VOY-101 Mid Dose (single dose, IVT) |
| High Dose | Experimental | Biological: VOY-101VOY-101 High Dose (single dose, IVT) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOY-101Intravitreal injection of VOY-101 | Biological | High Dose, Low Dose, Mid Dose |
Primary outcome
Safety Endpoints
Time frame: Through 24 months
1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VOY-101 in people with Age-related Macular Degeneration and Geographic Atrophy, run by Perceive Biotherapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoints (time frame: Through 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.