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

Primary Purpose

Age-related Macular Degeneration, Geographic Atrophy

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VOY-101

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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.

Sites / Locations

Retina Consultants of TexasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Low Dose

Mid Dose

High Dose

Randomized Cohort--MTD

Randomized Cohort--MTD-1

Randomized Cohort--Sham

Arm Description

VOY-101 Low Dose (single dose, IVT)

VOY-101 Mid Dose (single dose, IVT)

VOY-101 High Dose (single dose, IVT)

VOY-101 MTD (single dose, IVT)

VOY-101 Lower Dose than MTD (single dose, IVT)

Control arm (sham procedure)

Outcomes

Primary Outcome Measures

Safety Endpoints

1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])

Secondary Outcome Measures

Full Information

NCT ID

NCT05380492

First Posted

May 9, 2022

Last Updated

November 17, 2022

Sponsor

Perceive Biotherapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05380492

Brief Title

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

Official Title

Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 17, 2022 (Actual)

Primary Completion Date

November 2025 (Anticipated)

Study Completion Date

November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Perceive Biotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration, Geographic Atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

The Phase 1 will enroll in a dose escalation study model (three sequential cohorts), followed by a Phase 2a cohort that will be randomized among a maximum tolerated dose arm, a lower dose arm, and a control arm.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The Phase 1 cohorts will be open-label, the Phase 2a cohort will be masked.

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low Dose

Arm Type

Experimental

Arm Description

VOY-101 Low Dose (single dose, IVT)

Arm Title

Mid Dose

Arm Type

Experimental

Arm Description

VOY-101 Mid Dose (single dose, IVT)

Arm Title

High Dose

Arm Type

Experimental

Arm Description

VOY-101 High Dose (single dose, IVT)

Arm Title

Randomized Cohort--MTD

Arm Type

Active Comparator

Arm Description

VOY-101 MTD (single dose, IVT)

Arm Title

Randomized Cohort--MTD-1

Arm Type

Active Comparator

Arm Description

VOY-101 Lower Dose than MTD (single dose, IVT)

Arm Title

Randomized Cohort--Sham

Arm Type

Sham Comparator

Arm Description

Control arm (sham procedure)

Intervention Type

Biological

Intervention Name(s)

VOY-101

Intervention Description

Intravitreal injection of VOY-101

Primary Outcome Measure Information:

Title

Safety Endpoints

Description

1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])

Time Frame

Through 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Fung, MD

Phone

14153775678

annef@perceivebio.com

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Rubin, MBA

Phone

17074778172

anne@perceivebio.com

Facility Information:

Facility Name

Retina Consultants of Texas

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebbecca Taing

12. IPD Sharing Statement

Learn more about this trial

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

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