VOY-101 for Age-Related Macular Degeneration

Not currently recruiting at 2 trial locations

Overseen By Anne Fung, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Perceive Biotherapeutics, Inc.

Disqualifiers: Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Single dose

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called VOY-101 for age-related macular degeneration (AMD), a condition that can lead to vision loss. Researchers are assessing the safety of different doses of VOY-101 to determine the optimal amount for future studies. The trial includes several groups: low, mid, and high doses, along with a control group. Individuals with well-defined geographic atrophy due to AMD, without a history of abnormal blood vessel growth in the eye, might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how VOY-101 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

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 this trial's treatments are likely to be safe?

Research shows that VOY-101 has been tested in people with age-related macular degeneration (AMD). This treatment has undergone safety checks, but detailed information about side effects is not fully available yet. Since this trial primarily focuses on safety and is in the early stages, the main goal is to assess how well people tolerate different doses.

In similar studies, early trials usually aim to find the right dose and identify any side effects. This ensures the treatment is safe before advancing to more extensive testing. As VOY-101 remains in these early phases, researchers are gathering crucial information about its safety in humans. If VOY-101 had been approved for other uses, it would suggest some safety assurance, but that is not the case here.

While detailed safety data is not yet available, the early trial phase ensures careful monitoring of safety. Participants in this trial will help researchers understand how well VOY-101 is tolerated and identify any potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for macular degeneration?

Unlike the standard treatments for age-related macular degeneration (AMD) like anti-VEGF injections, which target blood vessel growth, VOY-101 offers a fresh approach by being administered through a single intravitreal injection at varying doses: low, mid, and high. This delivery method is designed to potentially reduce the frequency of treatments, which is a big win for patients who currently need frequent eye injections. Researchers are excited about VOY-101 because it aims to provide longer-lasting protection against vision loss, marking a significant advancement in AMD treatment options.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research has shown that VOY-101 could help treat age-related macular degeneration (AMD). Early results from clinical trials suggest that VOY-101, a new type of gene therapy, effectively treats geographic atrophy, a serious form of AMD. This treatment targets and possibly repairs damaged areas in the eye. Patients who received the therapy showed improvements in vision tests and eye scans. Although the treatment remains under study, these early results offer hope for people with AMD. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals over 50 with advanced non-neovascular age-related macular degeneration (AMD). Participants must be able to understand the study, provide consent, and commit to follow-up visits. They should have a specific form of AMD without signs of certain complications and meet genetic risk criteria.

Inclusion Criteria

Are willing and able to understand and provide written informed consent.

Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.

I have advanced AMD without any signs of MNV.

Exclusion Criteria

I do not have any other major health, eye, or inherited conditions.

I am not pregnant and willing to use effective birth control during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single, unilateral intravitreal injection of VOY-101 at one of three dose levels

Single dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• VOY-101

Trial Overview The study tests VOY-101 in patients with AMD. It starts by finding the highest dose people can tolerate without too many side effects (dose escalation), then compares that dose to a lower one and a control group to see which works best.

How Is the Trial Designed?

Group I: Mid Dose Experimental Treatment 1 Intervention

VOY-101 Mid Dose (single dose, IVT)

Group II: Low Dose Experimental Treatment 1 Intervention

VOY-101 Low Dose (single dose, IVT)

Group III: High Dose Experimental Treatment 1 Intervention

VOY-101 High Dose (single dose, IVT)

Who Is Running the Clinical Trial?

Perceive Biotherapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

190+

Published Research Related to This Trial

In a study of 1117 patients receiving anti-VEGF therapy for neovascular age-related macular degeneration, visual acuity was maintained over three years with an average of 15.3 injections, indicating the treatment's efficacy in a real-world setting.

The incidence of serious ocular adverse events, such as endophthalmitis, was very low at 0.086%, and there was no significant difference in adverse event rates between injections administered by nurses and those by physicians, suggesting the safety of the treatment regardless of the injector's qualifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration in real-life setting. Kataja, M., Hujanen, P., Huhtala, H., et al.[2022]

The incidence of nonocular serious adverse events in patients treated with intravitreal VEGF inhibitors for neovascular age-related macular degeneration varies widely, with reports ranging from 0% to 39.3%, indicating a potential risk that needs further investigation.

Patients with a history of cardiovascular issues, particularly stroke, may be at an increased risk for serious nonocular adverse events when treated with anti-VEGF agents, suggesting that caution is warranted in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic safety of intravitreal anti-vascular endothelial growth factor agents in age-related macular degeneration. Dedania, VS., Bakri, SJ.[2018]

In a study involving 5,781 patients over 24 months, intravitreal ranibizumab injections for treating eye conditions showed that 79.7% of patients reported no adverse events (AEs), indicating a generally favorable safety profile.

While 2,687 AEs were reported, with 30.3% classified as serious, the overall rate of AEs decreased over time, and no new safety concerns were identified, suggesting that ranibizumab is a safe option for patients under real-world conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial. Ziemssen, F., Hammer, T., Grueb, M., et al.[2022]

In a pooled analysis of safety data from 5 clinical trials involving 4,347 patients with neovascular age-related macular degeneration (nAMD), it was found that patients aged 85 years and older had a higher incidence of systemic serious adverse events (SAEs) compared to those younger than 85, indicating that age is a significant risk factor.

Despite the increased risk of SAEs in older patients, the use of ranibizumab did not significantly elevate the risk of most systemic SAEs, suggesting that the treatment is generally safe for elderly patients, although the analysis was limited by the small number of events for certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Systemic Safety of Ranibizumab in Patients 85 Years and Older with Neovascular Age-Related Macular Degeneration. Dugel, PU., Singh, N., Francom, S., et al.[2019]

In a study of 80 eyes from 66 patients treated with anti-VEGF for neovascular age-related macular degeneration over 10 years, significant vision loss was observed, with best-corrected visual acuity deteriorating from 0.55 to 1.00 LogMAR (p<0.0005).

The decrease in central subfield thickness was associated with genetic risk factors, showing that patients with more risk alleles for AMD had less reduction in macular thickness, indicating a potential link between genetics and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of neovascular age-related macular degeneration: association between treatment outcome and major risk alleles. Vofo, BN., Beykin, G., Levy, J., et al.[2023]

Citations

1. 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) .

2. 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.

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. 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 ...

5. 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.

6. 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, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1359644623002738

Therapeutic targeting of the complement system in ocular ... Current status of agents/complement therapeutics in development for the treatment of dry age-related macular degeneration (AMD) and/or geographic atrophy (GA) ...