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

April 10, 2024 updated by: Perceive Biotherapeutics, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Texas
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Are ≥50 years of age at the time of consent.
  2. Are willing and able to understand and provide written informed consent.
  3. Are willing and able to return for scheduled treatment and follow-up examinations.
  4. Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
  5. Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.
  6. Absence of signs of non-exudative MNV.
  7. Additional Ocular Inclusion Criteria
  8. Meet certain genotype criteria for risk of AMD.

Exclusion Criteria:

  1. 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.
  2. Additional Systemic, Ocular, and Genetic Exclusion Criteria.

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose
VOY-101 Low Dose (single dose, IVT)
Biological: VOY-101
Intravitreal injection of VOY-101
Experimental: Mid Dose
VOY-101 Mid Dose (single dose, IVT)
Biological: VOY-101
Intravitreal injection of VOY-101
Experimental: High Dose
VOY-101 High Dose (single dose, IVT)
Biological: VOY-101
Intravitreal injection of VOY-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Endpoints
Time Frame: Through 24 months
1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])
Through 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perceive Biotherapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2022

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBI-AMD-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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