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Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

PHASE1PHASE2RECRUITING

The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase 2a.

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Study details:

This is a prospective, open-label, multi-center Phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of escalating dose levels of VOY-101 therapy in subjects with advanced non-neovascular age-related macular degeneration (AMD).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 50 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-06-21

Primary completion: 2026-10-01

Study completion finish: 2027-10-01

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT06087458

Intervention or treatment

BIOLOGICAL: VOY-101

Conditions

• Age-Related Macular Degeneration

Image related to Age-Related Macular Degeneration

Condition: Age-Related Macular Degeneration
BIOLOGICAL: VOY-101
Sydney, New South Wales, Australia and more
Sponsor: Perceive Biotherapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Sydney Retina Clinic and Day Surgery

Research sites nearby

Select from list below to view details:

Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Cerulea Clinical Trials
East Melbourne, Victoria, Australia
Cabrini Research
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental: Low Single intravitreal injection of VOY-101	BIOLOGICAL: VOY-101 VOY-101
EXPERIMENTAL: Experimental: Medium Single intravitreal injection of VOY-101	BIOLOGICAL: VOY-101 VOY-101
EXPERIMENTAL: Experimental: High Single intravitreal injection of VOY-101	BIOLOGICAL: VOY-101 VOY-101
EXPERIMENTAL: Experimental: Higher Single intravitreal injection of VOY-101	BIOLOGICAL: VOY-101 VOY-101

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Safety and Tolerability as measured by frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])	Not Specified	24 months

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration