- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07660640
Long-Term Follow Up of VOY-101 Non-nAMD Extension Study (OASIS)
June 16, 2026 updated by: Perceive Biotherapeutics, Inc.
Long-Term Follow Up of VOY-101 for Advanced Non-Neovascular Age-Related Macular Degeneration Extension Study
Long-Term Follow Up Extension for participants previously enrolled in a VOY-101 study for Advanced Non-Neovascular Age-Related Macular Degeneration
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Detailed Description
This is a long-term observational, non-interventional extension study to the Phase 1/2a studies that administered VOY-101 to subjects with advanced non-neovascular age-related macular degeneration (AMD).
Study Type
Observational
Enrollment (Estimated)
88
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center - Ichilov
-
-
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Ophthalmic Consultants of Boston
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Texas
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Bellaire, Texas, United States, 77401
- Retina Consultants of Texas
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Rollover from PBI-AMD-001 and PBI-AMD-002 studies for those participants who received VOY-101
Description
Inclusion Criteria:
- Have received an injection of VOY-101 and exited either the PBI-AMD-001 or PBI-AMD-002 Phase 1/2a study of VOY-101.
- Are willing and able to understand and provide informed consent.
Exclusion Criteria:
There are no exclusion criteria for this study
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Rollover from PBI-AMD-001 and PBI-AMD-002 studies for those participants who received VOY-101
Long-term safety extension from PBI-AMD-001 and PBI-AMD-002 studies for those participants who received VOY-101
|
No intervention - observational study
One-time intravitreal injection of VOY-101.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of ocular and systemic VOY-101 related AEs
Time Frame: 3 years
|
Frequency of ocular and systemic VOY-101 related AEs (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs]).
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 3, 2026
Primary Completion (Estimated)
July 30, 2031
Study Completion (Estimated)
August 30, 2031
Study Registration Dates
First Submitted
June 16, 2026
First Submitted That Met QC Criteria
June 16, 2026
First Posted (Actual)
June 22, 2026
Study Record Updates
Last Update Posted (Actual)
June 22, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBI-AMD-901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
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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