VOY-101 for Age-Related Macular Degeneration

(JOURNEY Trial)

Recruiting at 12 trial locations

Overseen By Anne Fung, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Perceive Biotherapeutics, Inc.

Disqualifiers: Pregnancy, Women of childbearing potential, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VOY-101 for individuals with age-related macular degeneration (AMD), a condition causing vision loss in older adults. The main goal is to determine the safety of VOY-101 and its effects on the disease. Participants will receive a single eye injection of VOY-101, with the other eye serving as a comparison. Suitable candidates have well-defined areas of vision loss from AMD and no history of abnormal blood vessel growth in the eyes. As a Phase 1, Phase 2 trial, this study aims to understand how VOY-101 works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking AMD research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that VOY-101 is likely to be safe for humans?

Research shows that VOY-101 remains in the early stages of testing to determine its safety for people. Previous studies have not clearly demonstrated how well people tolerate this treatment or if any serious side effects exist. Since VOY-101 is undergoing early and mid-stage testing (Phase 1/2), the primary focus is on assessing its safety. Researchers closely monitor participants for any adverse reactions.

In these early stages, the main goal is to establish VOY-101's safety for people and identify any common side effects. Although detailed safety information is not yet available, these trials aim to detect any safety issues before the treatment progresses. Researchers carefully monitor participants throughout the study to ensure their well-being remains a top priority. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for age-related macular degeneration, which often include repeated injections of anti-VEGF drugs, VOY-101 offers a novel approach with a single intravitreal injection. Researchers are excited because VOY-101 may provide a longer-lasting effect with just one treatment, potentially reducing the frequency of injections needed. This could not only improve patient comfort and compliance but also lower the risk of complications associated with multiple injections.

What evidence suggests that VOY-101 might be an effective treatment for age-related macular degeneration?

Research has shown that VOY-101 holds promise as a treatment for age-related macular degeneration (AMD). Early clinical results suggest it could be effective. In this trial, participants will receive a single intravitreal injection of VOY-101, a new gene therapy targeting geographic atrophy, a severe form of AMD. The treatment aims to slow or stop vision damage. Initial findings indicate that patients who received VOY-101 experienced improvements or stabilization in their condition. These results offer hope for those with AMD. ^{1 2 6 7 8}

Who Is on the Research Team?

Anne Fung, MD

Principal Investigator

Perceive Biotherapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals over 50 with advanced non-neovascular age-related macular degeneration (AMD) who have not had previous MNV. Participants must be able to undergo specific vision tests and imaging, meet certain genetic risk criteria for AMD, and commit to follow-up visits.

Inclusion Criteria

You have specific ocular inclusion criteria for the study eye.

You are physically able to complete the Early Treatment Diabetic Retinopathy Study Best-Corrected Distance Visual Acuity and corresponding ocular imaging.

My eye condition is due to AMD without any signs of MNV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravitreal injection of VOY-101

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

96 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• VOY-101

Trial Overview The study is testing VOY-101 in a two-phase approach: an initial Phase 1 safety study with escalating doses followed by a Phase 2a. It aims to evaluate the effectiveness and safety of this potential new treatment for AMD.

How Is the Trial Designed?

Group I: VOY-101 Experimental Treatment 1 Intervention

Single intravitreal injection of VOY-101

Group II: Controll Active Control 1 Intervention

Fellow Eye

Who Is Running the Clinical Trial?

Perceive Biotherapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

190+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05380492

Study of VOY-101 in Patients With Advanced Non- ... 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.

2. europe.ophthalmologytimes.com europe.ophthalmologytimes.com/view/first-clinical-results-demonstrate-efficacy-of-voy-101-a-novel-gene-therapy-for-geographic-atrophy-asrs-omer-trivizki

First clinical results demonstrate efficacy of VOY-101, a ... Clinicians and industry partners continue the race to find the most efficacious therapy for age-related macular degeneration (AMD) .

3. trialx.com trialx.com/clinical-trials/listings/228385/study-of-voy-101-in-patients-with-advanced-non-neovascular-age-related-macular-degeneration-2/

Study of VOY-101 in Patients With Advanced Non- ... Clinical trial for Age-Related Macular Degeneration , Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular

4. clinicaltrial.be clinicaltrial.be/en/details/84288?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Study of VOY-101 in Patients With Advanced Non- ... ... VOY-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (AMD). Trial design. Interventions. 1. VOY-101.

5. withpower.com withpower.com/trial/phase-2-macular-degeneration-5-2023-de3d7

VOY-101 for Age-Related Macular Degeneration This trial is for individuals over 50 with advanced non-neovascular age-related macular degeneration (AMD) who have not had previous MNV.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06087458?cond=%22Retinal%20Degeneration%22&country=Australia&locStr=Australia&viewType=Table&rank=9

NCT06087458 | Study of VOY-101 in Patients With ... ... VOY-101 therapy in subjects with advanced non-neovascular age-related macular degeneration (AMD). Official Title. Phase 1/2a Dose Escalation Study of VOY-101 ...

7. withpower.com withpower.com/trial/phase-2-geographic-atrophy-6-2022-8063f

VOY-101 for Age-Related Macular Degeneration This trial is for individuals over 50 with advanced non-neovascular age-related macular degeneration (AMD). Participants must be able to understand the study, ...

8. ctv.veeva.com ctv.veeva.com/study/study-of-voy-101-in-patients-with-advanced-non-neovascular-age-related-macular-degeneration

Study of VOY-101 in Patients With Advanced Non ... ... VOY-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (AMD). Enrollment. 45 estimated patients. Sex. All.