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VOY-101 in Advanced Non-Neovascular Age-Related Macular Degeneration

Sponsor
Perceive Biotherapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06087458
Collaborator
(none)
66
Enrollment
4
Locations
2
Arms
51.4
Anticipated Duration (Months)
16.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Phase 1 safety study of VOY-101 comprises a two dose Cohort escalation, followed by a Phase 2a.

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

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Phase 1 will enroll in a dose escalation study model (two sequential cohorts), followed by a Phase 2a cohort that will be randomized among two arms.Phase 1 will enroll in a dose escalation study model (two sequential cohorts), followed by a Phase 2a cohort that will be randomized among two arms.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Actual Study Start Date :
Jun 21, 2023
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Low Dose

VOY-101 Low Dose (single dose, IVT)

Biological: VOY-101
VOY-101
Experimental: Experimental: High Dose

VOY-101 High Dose (single dose, IVT)

Biological: VOY-101
VOY-101

Outcome Measures

Primary Outcome Measures

  1. Safety Endpoints and tolerability [24 months]

    Evaluation of safety and tolerability on ocular and systemic assessments

Secondary Outcome Measures

  1. Change from baseline in laboratory assessments [24 months]

    Evaluation of laboratory measures from baseline through study termination

  2. Change from baseline in markers of inflammation [24 months]

    Evaluation of markers of inflammation from baseline through study termination

Eligibility Criteria

Criteria

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

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sydney Retina Clinic and Day Surgery Sydney New South Wales Australia 2000
2 Centre for Eye Research Australia (CERA) Melbourne Victoria Australia 3002
3 Cabrini Research Melbourne Victoria Australia 3144
4 Tel-Aviv Sourasky Medical Center, Ophthalmology Division Tel Aviv Israel 64239

Sponsors and Collaborators

  • Perceive Biotherapeutics, Inc.

Investigators

  • Study Director: Anne Fung, MD, Perceive Biotherapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Perceive Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT06087458
Other Study ID Numbers:
  • PBI-AMD-002
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Oct 19, 2023