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New treatment option for Geographic Atrophy Secondary to Age-related Macular Degeneration
Official title A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration
ClinicalTrials.gov ID: NCT06765980
What this study is testing
What is VV-14295?
VV-14295 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for geographic atrophy secondary to age-related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to evaluate how safe and tolerable KRIYA-825 (VV-14295) is and to determine how effective it is in reducing the growth of geographic atrophy (GA) lesions in the treated eye in patients with GA secondary to age-related macular degeneration (AMD).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 80
You may be able to join if
- Participant must be between 55 to 80 years of age (inclusive), at the time of signing the informed consent form.
- Body mass index (BMI) of 19 to 34 kg/m2 (inclusive).
- Must agree to use reliable contraception for at least 12 months after administration of VV-14295. A female participant is eligible to participate if...
- The GA lesion must meet certain criteria as assessed by a central reading center's assessment of imaging at Screening.
- Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the...
You likely can't join if
- Any ocular disease or condition that is not GA secondary to AMD: Macular atrophy secondary to a condition other than AMD; Exudative AMD diagnosis or...
- Any ocular condition that prevents adequate imaging.
- Medical, cognitive or psychiatric conditions that, in the opinion of the Investigator, make consistent study assessment and follow-up over the...
- Hospitalization within 1 year prior to Screening that, in the opinion of the Investigator, make consistent study assessment and follow-up over the...
- Any Screening test (e.g., ECG) or laboratory value (e.g., hematology) that in the opinion of the Investigator and/or Medical Monitor is clinically...
- Participant has a direct contraindication to the steroid regimen (both oral and topical) or has a condition that significantly increases the risk of...
See the full eligibility criteria
- Participant must be between 55 to 80 years of age (inclusive), at the time of signing the informed consent form.
- Body mass index (BMI) of 19 to 34 kg/m2 (inclusive).
- Must agree to use reliable contraception for at least 12 months after administration of VV-14295. A female participant is eligible to participate if she is not pregnant and not breastfeeding.
- The GA lesion must meet certain criteria as assessed by a central reading center's assessment of imaging at Screening.
- Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
- For study eye, Normal Luminance BCVA of 55 letters or worse using the ETDRS charts (20/80 or worse) for Part 1a participants or 24 letters or better (approximately 20/320 Snellen equivalent) for Part 1b and Part 2...
- Fellow eye Normal Luminance BCVA of 5 letters or better using ETDRS charts (20/800 or better) for Part 1a participants or 24 letters or better (approximately 20/320 Snellen equivalent or better) for Part 1b and Part 2...
- Any ocular disease or condition that is not GA secondary to AMD: Macular atrophy secondary to a condition other than AMD; Exudative AMD diagnosis or any history of or active macular neovascularization (in study eye or...
- Any ocular condition that prevents adequate imaging.
- Medical, cognitive or psychiatric conditions that, in the opinion of the Investigator, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the...
- Hospitalization within 1 year prior to Screening that, in the opinion of the Investigator, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the...
- Any Screening test (e.g., ECG) or laboratory value (e.g., hematology) that in the opinion of the Investigator and/or Medical Monitor is clinically significant and renders the participant not suitable for study...
- Participant has a direct contraindication to the steroid regimen (both oral and topical) or has a condition that significantly increases the risk of complication.
- Active/history of malignancy within the past 5 years from Screening or any previous therapeutic radiation in the region of the study eye(s) at Screening. History of non-melanoma skin cancers (e.g., basal cell, squamous...
- Intraocular surgery (including lens replacement surgery) within 3 months prior to Screening.
- History of laser therapy in the macular region.
- History of intravitreal (IVT) therapy, such as IVT steroid injections, within 6 months prior to Screening.
- COVID-19 vaccine within 90 days of Screening or plan to receive COVID-19 vaccine within 6 months of treatment.
- Active use of systemic immunomodulatory drugs or systemic corticosteroids in the last 60 days. Topical steroids are not exclusionary.
- Prior participation in another treatment clinical study for GA within the past 12 months from the last dosing at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
- Tel Aviv, Israel
- Christchurch, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada; Tel Aviv, Israel; Christchurch, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.