Age-Related Macular Degeneration, Geographic Atrophy, Non-neovascular Age-related Macular Degeneration, Non-neovascular AMD
Conditions
Brief summary
The Phase 1 safety study of VOY-101 is comprised of escalating dose Cohorts, followed by a Phase 2 at the recommended phase 2 dose.
Detailed description
The study has a prospective, open-label, multi-center, two-part design to evaluate a single, unilateral intravitreal (IVT) injection of VOY-101 in subjects with geographic atrophy (GA), the advanced form of non-neovascular age-related macular degeneration (AMD). Phase 1 followed a standard dose escalation model to establish safety and tolerability of VOY-101 and determine the recommended phase 2 dose. This dose is being used in the randomized Phase 2 part of the study to evaluate the safety and efficacy of VOY-101 in the study eye compared to untreated fellow eye.
Interventions
BIOLOGICALVOY-101
VOY-101
Sponsors
Perceive Biotherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Central Reading Center is masked.
Intervention model description
Phase 1 follows a standard dose escalation model to evaluate safety and tolerability of VOY-101 and recommended Phase 2a dose (RP2D). This dose will be used in Phase 2a to evaluate the safety and efficacy of VOY-101 in the study eye compared to untreated fellow eye.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV for both eyes. * Absence of signs of non-exudative MNV. * Additional Ocular Inclusion Criteria for both eyes. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101 | 24 Months | Frequency and type of ocular and systemic adverse events and non-serious treatment-emergent adverse events |
| Phase 1: Change from Baseline in markers of inflammation | Baseline to Month 24 | Change from Baseline in markers of inflammation including anterior chamber cells, vitreous cells, and retinal vasculitis and retinitis. |
| Phase 1: Establish the recommended Phase 2 dose in subjects with Geographic Atrophy. | Month 12 | Determine whether the maximum tolerated dose (MTD) has been reached (as determined by the occurrence of dose-limiting toxicities \[DLTs\]) and select the RP2D. |
| Phase 2: To evaluate the effect of VOY-101 in the study eye compared with untreated fellow eye on change in Geographic Atrophy lesion size. | 15 Months | Change from Baseline in Geographic Atrophy lesion size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: To evaluate the effect of VOY-101 on geographic atrophy lesion size and photoreceptors | Baseline through 24 Months | Growth rate of total geographic atrophy lesion size and photoreceptor change |
| Phase 1/2: To establish the pharmacokinetic (PK) profile of VOY-101. | Baseline through 24 Months | Change from Baseline for complement levels in aqueous humor |
| Phase 1/2: To evaluate the effect of VOY-101 on best corrected distance visual acuity | 24 Months | Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA and Percentage of subjects with \<15 letters lost in BCDVA from Treatment |
| Phase 1/2: Development of macular neovascularization | Month 24 | Incidence, frequency, severity, and timing of development of macular neovascularization |
| Phase 2: To further characterize the ocular and systemic safety and tolerability of VOY-101 | 24 Months | Frequency of Investigational Product related ocular and systemic adverse events, adverse events of special interest and non-serious treatment-emergent adverse events. |
| Phase 2: To evaluate the effect of VOY-101 in the study eye compared with untreated fellow eye on geographic atrophy lesion size and photoreceptors | Baseline through Month 24 | Change in geographic atrophy lesion size and rate of photoreceptor loss |
| Phase 2: To evaluate the effect of VOY-101 on low luminance visual acuity | Baseline through Month 24 | Change from Baseline in the change in visual function using Early Treatment Diabetic Retinopathy Study (ETDRS) Low Luminance Visual (LLVA) vision test |
Countries
Australia, Israel, United States
Contacts
STUDY_DIRECTORAnne Fung, MD
Perceive Biotherapeutics, Inc.
Outcome results
None listed