Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorPerceive Biotherapeutics, Inc.
About this trial
The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase 2a.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are ≥60 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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
VOY-101
Biological/VaccineVOY-101
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: VOY-101Experimental treatment 1 intervention
Group B: ControllNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Overall effect of treatment on retinal structural health
GA growth rate and Change in Ellipsoid Zone Integrity
Time frame
Week 48Secondary outcomes
1
Overall effect of treatment on retinal structural health
GA Growth Rate and Change in Ellipsoid Zone Integrity
Time frame
Weeks 36, 48, and 962
Effect of treatment on vision function
Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA and LLVA and microperimetry.
Time frame
Change from baseline3
Incidence of neovascular AMD
Incidence, frequency, severity, and timing of development of neovascular AMD
Time frame
Baseline to Week 964
VOY-101 Safety
Frequency of related ocular and systemic AEs (SAEs and non-serious), adverse events of special interest (AESI) and non-serious TEAEs).
Time frame
Baseline to Week 96Sponsors and contacts
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Source ClinicalTrials.gov