Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration (JOURNEY)
Fase 1/2a doseeskaleringsstudie av VOY-101 hos pasienter med avansert ikke-neovaskulær aldersrelatert makuladegenerasjon
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2000
- Sydney Retina Clinic and Day Surgery
-
-
Victoria
-
East Melbourne, Victoria, Australia, 3002
- Cerulea Clinical Trials
-
-
-
-
Arizona
-
Scottsdale, Arizona, Forente stater, 85255
- Retina Macula Institute of AZ
-
-
California
-
Poway, California, Forente stater, 92064
- Retina Consultants San Diego
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Sacramento, California, Forente stater, 95825
- Retinal Consultants Medical Group
-
-
Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Ophthalmic Consultants of Boston
-
-
Missouri
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St Louis, Missouri, Forente stater, 63128
- The Retina Institute
-
-
New Jersey
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Cherry Hill, New Jersey, Forente stater, 08034
- Mid Atlantic Retina
-
-
Oregon
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Portland, Oregon, Forente stater, 97221
- Retina Northwest
-
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Black Hills Regional Eye Institute
-
-
Texas
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Austin, Texas, Forente stater, 78705
- Austin Research Center for Retina
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Fort Worth, Texas, Forente stater, 76132
- Star Retina
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Southlake, Texas, Forente stater, 76092
- Retina Center of Texas
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Utah
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Salt Lake City, Utah, Forente stater, 84132
- University of Utah John A. Moran Eye Center
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-
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Haifa, Israel
- Rambam Medical Center
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Tel Aviv, Israel, 64239
- Tel-Aviv Sourasky Medical Center, Ophthalmology Division
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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 Exclusion Criteria.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Low
Single, unilateral, intravitreal injection of low dose of VOY-101 |
VOY-101 |
|
Eksperimentell: Medium
Single, unilateral, intravitreal injection of medium dose of VOY-101 |
VOY-101 |
|
Eksperimentell: High
Single, unilateral, intravitreal injection of high dose of VOY-101 |
VOY-101 |
|
Eksperimentell: Higher
Single, unilateral, intravitreal injection of higher dose of VOY-101 |
VOY-101 |
|
Eksperimentell: Intermediate
Single, unilateral, intravitreal injection of intermediate dose of VOY-101 |
VOY-101 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101
Tidsramme: 24 Months
|
Frequency and type of ocular and systemic adverse events and non-serious treatment-emergent adverse events |
24 Months
|
|
Phase 1: Change from Baseline in markers of inflammation
Tidsramme: Baseline to Month 24
|
Change from Baseline in markers of inflammation including anterior chamber cells, vitreous cells, and retinal vasculitis and retinitis. |
Baseline to Month 24
|
|
Phase 1: Establish the recommended Phase 2 dose in subjects with Geographic Atrophy.
Tidsramme: 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. |
Month 12
|
|
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.
Tidsramme: 15 Months
|
Change from Baseline in Geographic Atrophy lesion size |
15 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase 1: To evaluate the effect of VOY-101 on geographic atrophy lesion size and photoreceptors
Tidsramme: Baseline through 24 Months
|
Growth rate of total geographic atrophy lesion size and photoreceptor change |
Baseline through 24 Months
|
|
Phase 1/2: To establish the pharmacokinetic (PK) profile of VOY-101.
Tidsramme: Baseline through 24 Months
|
Change from Baseline for complement levels in aqueous humor |
Baseline through 24 Months
|
|
Phase 1/2: To evaluate the effect of VOY-101 on best corrected distance visual acuity
Tidsramme: 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 |
24 Months
|
|
Phase 1/2: Development of macular neovascularization
Tidsramme: Month 24
|
Incidence, frequency, severity, and timing of development of macular neovascularization |
Month 24
|
|
Phase 2: To further characterize the ocular and systemic safety and tolerability of VOY-101
Tidsramme: 24 Months
|
Frequency of Investigational Product related ocular and systemic adverse events, adverse events of special interest and non-serious treatment-emergent adverse events. |
24 Months
|
|
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
Tidsramme: Baseline through Month 24
|
Change in geographic atrophy lesion size and rate of photoreceptor loss |
Baseline through Month 24
|
|
Phase 2: To evaluate the effect of VOY-101 on low luminance visual acuity
Tidsramme: 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 |
Baseline through Month 24
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Anne Fung, MD, Perceive Biotherapeutics, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PBI-AMD-002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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