Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05380492




Registration number
NCT05380492
Ethics application status
Date submitted
9/05/2022
Date registered
19/05/2022
Date last updated
22/11/2022

Titles & IDs
Public title
Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Scientific title
Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Secondary ID [1] 0 0
PBI-AMD-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related Macular Degeneration 0 0
Geographic Atrophy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - VOY-101

Experimental: Low Dose - VOY-101 Low Dose (single dose, IVT)

Experimental: Mid Dose - VOY-101 Mid Dose (single dose, IVT)

Experimental: High Dose - VOY-101 High Dose (single dose, IVT)

Active Comparator: Randomized Cohort--MTD - VOY-101 MTD (single dose, IVT)

Active Comparator: Randomized Cohort--MTD-1 - VOY-101 Lower Dose than MTD (single dose, IVT)

Sham Comparator: Randomized Cohort--Sham - Control arm (sham procedure)


Other interventions: VOY-101
Intravitreal injection of VOY-101
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Endpoints
Timepoint [1] 0 0
Through 24 months

Eligibility
Key inclusion criteria
1. Are =50 years of age at the time of consent.

2. Are willing and able to understand and provide written informed consent.

3. Are willing and able to return for scheduled treatment and follow-up examinations.

4. Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.

5. Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of
history of MNV.

6. Absence of signs of non-exudative MNV.

7. Additional Ocular Inclusion Criteria

8. Meet certain genotype criteria for risk of AMD.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.

2. Additional Systemic, Ocular, and Genetic Exclusion Criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Perceive Biotherapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05380492
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anne Fung, MD
Address 0 0
Country 0 0
Phone 0 0
14153775678
Fax 0 0
Email 0 0
annef@perceivebio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05380492