Age-Related Macular DegenerationPhase 1/2JOURNEYNCT06087458

Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

A Phase 1/2 study testing VOY-101 in people with Age-Related Macular Degeneration and Geographic Atrophy, run by Perceive Biotherapeutics, Inc. at 16 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Age-Related Macular Degeneration, Geographic Atrophy, Non-neovascular AMD
What is being tested?: VOY-101
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 16 sitesin 3 countries
Study dates: 21 Jun 2023to Jun 2028
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

16 sites in 3 countries.

Country

City, postcode or hospital

16 sites in 3 countries

United States12 sites

Austin Research Center for Retina
Austin, Texas, 78705
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Mid Atlantic Retina
Cherry Hill, New Jersey, 08034
Star Retina
Fort Worth, Texas, 76132
Retina Northwest
Portland, Oregon, 97221
Retina Consultants San Diego
Poway, California, 92064
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Retinal Consultants Medical Group
Sacramento, California, 95825
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, 84132
Retina Macula Institute of AZ
Scottsdale, Arizona, 85255
Retina Center of Texas
Southlake, Texas, 76092
The Retina Institute
St Louis, Missouri, 63128

Other trials in United States

Australia2 sites

Cerulea Clinical Trials
East Melbourne, Victoria, 3002
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000

Other trials in Australia

Israel2 sites

Rambam Medical Center
Haifa
Tel-Aviv Sourasky Medical Center, Ophthalmology Division
Tel Aviv, 64239

Other trials in Israel

About this study

Official title: Phase 1/2a Study of VOY-101 in Subjects With Advanced Non-Neovascular Age-Related Macular Degeneration (JOURNEY)

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.

Read the 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.

Conditions: Age-Related Macular Degeneration, Geographic Atrophy, Non-neovascular AMD, Non-neovascular Age-related Macular Degeneration
Being tested: VOY-101
Medical subject headings: Macular Degeneration, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VOY-101Biological
VOY-101

Study groups in NCT06087458
Study group	Role	What they receive
Low	Experimental	Single, unilateral, intravitreal injection of low dose of VOY-101 Receives: Biological: VOY-101
Medium	Experimental	Single, unilateral, intravitreal injection of medium dose of VOY-101 Receives: Biological: VOY-101
High	Experimental	Single, unilateral, intravitreal injection of high dose of VOY-101 Receives: Biological: VOY-101
Higher	Experimental	Single, unilateral, intravitreal injection of higher dose of VOY-101 Receives: Biological: VOY-101
Intermediate	Experimental	Single, unilateral, intravitreal injection of intermediate dose of VOY-101 Receives: Biological: VOY-101

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101
Frequency and type of ocular and systemic adverse events and non-serious treatment-emergent adverse events
Measured: 24 Months
Phase 1: Change from Baseline in markers of inflammation
Change from Baseline in markers of inflammation including anterior chamber cells, vitreous cells, and retinal vasculitis and retinitis.
Measured: Baseline to Month 24
Phase 1: Establish the recommended Phase 2 dose in subjects with Geographic Atrophy.
Determine whether the maximum tolerated dose (MTD) has been reached (as determined by the occurrence of dose-limiting toxicities [DLTs]) and select the RP2D.
Measured: 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.
Change from Baseline in Geographic Atrophy lesion size
Measured: 15 Months

Secondary outcomes (7)

Phase 1: To evaluate the effect of VOY-101 on geographic atrophy lesion size and photoreceptors
Growth rate of total geographic atrophy lesion size and photoreceptor change
Measured: Baseline through 24 Months
Phase 1/2: To establish the pharmacokinetic (PK) profile of VOY-101.
Change from Baseline for complement levels in aqueous humor
Measured: Baseline through 24 Months
Phase 1/2: To evaluate the effect of VOY-101 on best corrected distance visual acuity
Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA and Percentage of subjects with <15 letters lost in BCDVA from Treatment
Measured: 24 Months
Phase 1/2: Development of macular neovascularization
Incidence, frequency, severity, and timing of development of macular neovascularization
Measured: Month 24
Phase 2: To further characterize the ocular and systemic safety and tolerability of VOY-101
Frequency of Investigational Product related ocular and systemic adverse events, adverse events of special interest and non-serious treatment-emergent adverse events.
Measured: 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
Change in geographic atrophy lesion size and rate of photoreceptor loss
Measured: Baseline through Month 24
Phase 2: To evaluate the effect of VOY-101 on low luminance visual acuity
Change from Baseline in the change in visual function using Early Treatment Diabetic Retinopathy Study (ETDRS) Low Luminance Visual (LLVA) vision test
Measured: Baseline through Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 2023Jun 2028

First posted17 Oct 2023
Study start21 Jun 2023
Primary completionOct 2027 (estimated)
Study completionJun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06087458
Sponsor's protocol ID: PBI-AMD-002
Acronym: JOURNEY
Status last verified: Aug 2026
First submitted: 12 Oct 2023
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Age-Related Macular Degeneration
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Blepharoptosis After Repeated Intravitreal Anti-VEGF Injections: A Prospective Study
Blepharoptosis, Age-Related Macular Degeneration
Recruiting
Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery
Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer
Not yet recruitingObservational study
Prevalence of Age-Related Macular Degeneration in Assiut University Hospitals
Age-Related Macular Degeneration (AMD)