VOY-101 for Age-Related Macular Degeneration

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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the safety of VOY-101, an eye injection, in patients with severe AMD that doesn't involve abnormal blood vessel growth. The goal is to see if this treatment can help manage their condition.

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.

What data supports the effectiveness of the drug VOY-101 for age-related macular degeneration?

Research shows that drugs similar to VOY-101, known as anti-VEGF agents, have improved vision in patients with age-related macular degeneration by an average of 5.37 letters on an eye chart over 12 months. ^{1 2 3 4 5}

What safety data exists for VOY-101 in humans?

The safety of treatments similar to VOY-101, like ranibizumab, has been studied in people with age-related macular degeneration. These studies generally show that while there are some risks, such as non-eye-related side effects, the treatment is considered safe for many patients, including those over 85 years old. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Estimating the yearly number of eyes with treatable neovascular age-related macular degeneration using a direct standardization method and a markov model. [2006]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Managing Neovascular Age-Related Macular Degeneration in Clinical Practice: Systematic Review, Meta-Analysis, and Meta-Regression. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Long-term outcome of neovascular age-related macular degeneration: association between treatment outcome and major risk alleles. [2023]

5. France pubmed.ncbi.nlm.nih.gov

[Management of wet AMD in France in 2015]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Outcome of anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration in real-life setting. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The Systemic Safety of Ranibizumab in Patients 85 Years and Older with Neovascular Age-Related Macular Degeneration. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial. [2022]