What is the mechanism of action of this treatment?

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF therapies, photodynamic therapy, and antioxidant vitamins. Anti-VEGF therapies work by inhibiting the growth of abnormal blood vessels and reducing fluid leakage in the retina, which is crucial for preventing vision loss. Photodynamic therapy involves using a light-activated drug to destroy abnormal blood vessels. Antioxidant vitamins help protect retinal cells from oxidative damage. These treatments are essential for AMD patients as they target the primary mechanisms of disease progression, thereby preserving vision and improving quality of life.

What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF injections, photodynamic therapy, and laser therapy. Anti-VEGF treatments, such as ranibizumab and aflibercept, can cause side effects like eye pain, increased intraocular pressure, vitreous floaters, and rarely, retinal detachment or endophthalmitis. Photodynamic therapy may lead to temporary vision changes, photosensitivity, and inflammation. Laser therapy can result in scarring and potential vision loss in treated areas. These treatments aim to manage the progression of AMD and improve vision-related outcomes.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD), primarily focusing on anti-VEGF (vascular endothelial growth factor) therapies. These include drugs like ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin), which are used to inhibit abnormal blood vessel growth and leakage in the eye. These treatments are administered via intravitreal injections and have shown efficacy in reducing vision loss in patients with neovascular (wet) AMD. The trial VOY-101, which is a safety study for advanced non-neovascular (dry) AMD, represents a different approach, potentially expanding the treatment options for AMD beyond the current anti-VEGF therapies.

What other types of research exist?

Promising novel alternatives to VOY-101 for Age-Related Macular Degeneration patients include: 1) Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, which has shown positive results in clinical trials for neovascular AMD. 2) Gene therapy options like RGX-314, which aims to provide a long-term solution by delivering a gene encoding for an anti-VEGF protein. 3) Complement inhibitors such as Pegcetacoplan, which targets the complement system and has shown promise in reducing the progression of geographic atrophy in AMD.

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VOY-101 for Age-Related Macular Degeneration

Phase 1 & 2

Waitlist Available

Research Sponsored by Perceive Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.

Are ≥50 years of age at the time of consent.

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical ones from similar eye treatments may include discomfort at the injection site, increased eye pressure, inflammation inside the eye, bleeding or infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have advanced AMD without any signs of MNV.

Select...

I am 50 years old or older.

Select...

My genetic test shows I'm at risk for AMD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety Endpoints

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Mid DoseExperimental Treatment1 Intervention

VOY-101 Mid Dose (single dose, IVT)

Group II: Low DoseExperimental Treatment1 Intervention

VOY-101 Low Dose (single dose, IVT)

Group III: High DoseExperimental Treatment1 Intervention

VOY-101 High Dose (single dose, IVT)

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF therapies, photodynamic therapy, and antioxidant vitamins. Anti-VEGF therapies work by inhibiting the growth of abnormal blood vessels and reducing fluid leakage in the retina, which is crucial for preventing vision loss. Photodynamic therapy involves using a light-activated drug to destroy abnormal blood vessels. Antioxidant vitamins help protect retinal cells from oxidative damage. These treatments are essential for AMD patients as they target the primary mechanisms of disease progression, thereby preserving vision and improving quality of life.