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

Last updated: April 10, 2024
Sponsor: Perceive Biotherapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Geographic Atrophy

Macular Degeneration

Aging

Treatment

VOY-101

Clinical Study ID

NCT05380492
PBI-AMD-001
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofhistory 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

Exclusion Criteria:

  1. Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use anddocument use of effective contraception for the duration of the study.
  2. Additional Systemic, Ocular, and Genetic Exclusion Criteria.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: VOY-101
Phase: 1/2
Study Start date:
November 17, 2022
Estimated Completion Date:
November 30, 2025

Study 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).

Connect with a study center

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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