Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - 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


Treatment: Other: VOY-101
VOY-101
Intervention code [1] 0 0
Treatment: Other
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
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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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