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/NCT06087458




Registration number
NCT06087458
Ethics application status
Date submitted
12/10/2023
Date registered
17/10/2023
Date last updated
23/04/2024

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-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 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: Experimental: Dose 1 - Single intravitreal injection of VOY-101

Experimental: Experimental: Dose 2 - Single intravitreal injection of VOY-101

Experimental: Experimental: Dose 3 - Single intravitreal injection of VOY-101

Experimental: Experimental: Dose 4 - Single intravitreal injection of VOY-101


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

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

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
21/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [2] 0 0
Centre for Eye Research Australia (CERA) - Melbourne
Recruitment hospital [3] 0 0
Cabrini Research - Melbourne
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - Melbourne
Recruitment postcode(s) [3] 0 0
3144 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Tel Aviv

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

Ethics approval
Ethics application status

Summary
Brief summary
The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase
2a.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06087458
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Fung, MD
Address 0 0
Perceive Biotherapeutics, Inc.
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
(800) 867-7960
Fax 0 0
Email 0 0
Voy101clinical@perceivebio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06087458