Clincosm LogoSign in Get a demo

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

Sponsor
Perceive Biotherapeutics, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05380492
Collaborator
(none)
35
Enrollment
3
Arms
48
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: VOY-101
 Phase 1/Phase 2

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 two dose levels of VOY-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (AMD).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
The Phase 1 will enroll in a dose escalation study model (two 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.The Phase 1 will enroll in a dose escalation study model (two 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:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The Phase 1 cohorts will be open-label, the Phase 2a cohort will be masked.
Primary Purpose:
Treatment
Official Title:
Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low Dose

VOY-101 Low 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
Experimental: Randomized Cohort

VOY-101 MTD or Lower Dose (single dose, IVT) or Control arm (sham procedure)

Biological: VOY-101
Intravitreal injection of VOY-101

Outcome Measures

Primary Outcome Measures

  1. Safety Endpoints [Through 24 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Perceive Biotherapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Perceive Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05380492
Other Study ID Numbers:
  • PBI-AMD-001
First Posted:
May 19, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
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
Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy

Study Results

No Results Posted as of May 19, 2022