Study of VOY-101 in Patients With Advanced Non-Neovascula... | NCT06087458

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2023Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Mar 2028Estimated

First Submitted Date

Oct 12, 2023

First Submission Date that Met QC Criteria

Oct 12, 2023

First Posted Date

Oct 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2025

Last Update Posted Date

Oct 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VOY-101	Experimental	Single intravitreal injection of VOY-101	Biological: VOY-101
Controll	No Intervention	Fellow Eye

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VOY-101	Biological	VOY-101	VOY-101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall effect of treatment on retinal structural health	GA growth rate and Change in Ellipsoid Zone Integrity	Week 48

Secondary Outcomes

Measure	Description	Time Frame
Overall effect of treatment on retinal structural health	GA Growth Rate and Change in Ellipsoid Zone Integrity	Weeks 36, 48, and 96
Effect of treatment on vision function	Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA and LLVA and microperimetry.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are ≥60 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 for both eyes.
Absence of signs of non-exudative MNV.
Additional Ocular Inclusion Criteria for both eyes.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne Fung, MD	Contact	(800) 867-7960		Voy101clinical@perceivebio.com

Overall Officials

Name	Affiliation	Role
Anne Fung, MD	Perceive Biotherapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Macula Institute of AZ	Recruiting	Scottsdale	Arizona	85255	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Intervention Model Description

Phase 1 follows a standard dose escalation model to evaluate safety and tolerability of VOY-101 and recommended Phase 2a dose (RP2D). This dose will be used in Phase 2a to evaluate the safety and efficacy of VOY-101 in the study eye compared to untreated fellow eye.

ID	Term
D008268	Macular Degeneration
D057092	Geographic Atrophy

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases