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Aktiv men inte rekryterandePHASE4INTERVENTIONELL

A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

This study is investigating a treatment called faricimab for 'wet' Age-related Macular Degeneration (nAMD), a common eye condition that can lead to blurred vision. Researchers want to understand how effective faricimab is at improving or maintaining vision, how safe it is for patients, and how long its effects last. The study will look at giving faricimab injections into the eye at longer intervals, up to every 24 weeks, for people who haven't had previous treatment for their nAMD. It's a large, long-term study that will involve many medical centres and last for 100 weeks (nearly two years).

Överblick

Status
Aktiv men inte rekryterande
Fas
PHASE4
Sponsor
Hoffmann-La Roche
Inskrivningsmål
274
Starta
14 mars 2025
Beräknad slutförande
20 sep 2027

Vad handlar denna studie om?

This research study is about a treatment called faricimab for a specific eye condition known as 'wet' Age-related Macular Degeneration (nAMD). This condition causes blurred vision or blind spots because abnormal blood vessels grow at the back of the eye and leak fluid. Faricimab is a medicine designed to stop these leaks, helping to protect or improve your eyesight.

The main goals of this study are to see how well faricimab works (its 'efficacy') for people newly diagnosed with nAMD, how safe it is to use, and how long its benefits last (its 'durability'). An important aspect of this study is exploring if faricimab can be given less frequently, specifically up to every 24 weeks (about every six months), which could mean fewer clinic visits and injections for patients compared to current treatments.

This is a 'Phase IIIb/IV' study, which means it builds on earlier research that showed faricimab is promising. It's a large-scale study involving many different hospitals or clinics (multicenter). For 100 weeks (nearly two years), researchers will carefully follow participants to gather detailed information about the treatment's effects. The study will help doctors understand the best way to use faricimab to help people with nAMD.

Viktiga punkter

  • Investigating a new treatment (faricimab) for 'wet' Age-related Macular Degeneration (nAMD).
  • Aims to assess efficacy, safety, and how long benefits last with less frequent injections.
  • Specifically for people newly diagnosed with nAMD who haven't had prior treatment.
  • The study lasts for 100 weeks (nearly two years).
  • Involves regular eye check-ups and injections into the eye.
  • Participation is voluntary, with the right to withdraw at any time.

Vem kan vara berättigad?

To join this study, participants generally need to be in good health. Your doctor will carry out medical checks to make sure you're suitable. You'll also need to agree to use contraception methods described in the study rules if they apply to you.

Key requirements for the eye being studied include having 'wet' Age-related Macular Degeneration (nAMD) for the first time – meaning you haven't received previous treatment for it. Your doctor will confirm this based on scans of your eye. Your vision in the study eye also needs to be within a certain range (between 20/25 and 20/320 on a standard eye chart).

There are reasons you might not be able to join. For example, if your nAMD is caused by something other than age-related issues, or if you have certain other eye problems like bleeding in the eye or a history of eye inflammation. If you've previously had injections or treatments for other retinal conditions in the study eye, you generally won't be able to participate. Also, if your other eye (the non-study eye) has very poor vision or is not present, you might not be eligible.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. Är jag generellt vid god hälsa?
  2. Do I have 'wet' Age-related Macular Degeneration (nAMD) in one eye that hasn't been treated before?
  3. Is my vision in the affected eye within a certain range (not too good, not too poor)?
  4. Do I have any other significant eye conditions like bleeding or inflammation that might exclude me?
  5. Have I had any previous injections or treatments in the eye being studied for other retinal diseases?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

If you join this study, it will last for 100 weeks, which is almost two years. You'll receive injections of faricimab into your study eye. The aim is to see if these injections can be given as infrequently as every 24 weeks (about every six months), but the exact schedule might vary depending on your individual response. Throughout the study, you'll have regular visits to the clinic for eye exams, vision tests, and scans of your eye to monitor your condition and how you're responding to the treatment. These visits will help doctors assess the effectiveness and safety of faricimab. All procedures and examinations will be clearly explained to you.

Potentiella risker och fördelar

Participating in this study might offer potential benefits, such as receiving a new treatment for your 'wet' AMD that could help maintain or improve your vision. You will also be closely monitored by medical professionals throughout the study. However, like all medical treatments, there are potential risks, including side effects from the medication or the eye injection procedure itself. These will be fully explained to you before you decide to take part. Remember, joining a clinical study is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (67)

  • Orange County Retina Medical Group
    Verifierat postnummer
    Santa Ana, USA
  • Florida Retina Institute
    Verifierat postnummer
    Orlando, USA
  • Ctr for Retina & Macular Dis
    Verifierat postnummer
    Winter Haven, United States
  • Retinal Vitreal Consultants
    Verifierat postnummer
    Chicago, USA
  • University Retina and Macula Associates, PC
    Verifierat postnummer
    Lemont, United States
  • New England Retina Consultants
    Verifierat postnummer
    Springfield, USA
  • Sierra Eye Associates
    Verifierat postnummer
    Sparks, United States
  • Retina Associates of New Jersey
    Verifierat postnummer
    Teaneck, United States
  • Vision Research Center at Eye Associates of New Mexico
    Verifierat postnummer
    Albuquerque, United States
  • Charles Retina Institute
    Verifierat postnummer
    Germantown, United States
  • Retina Consultants of Texas
    Verifierat postnummer
    Schertz, United States
  • Strathfield Retina Clinic
    Verifierat postnummer
    Strathfield, Australia

Vanliga frågor

What is 'wet' Age-related Macular Degeneration (nAMD)?

It's an eye condition where abnormal blood vessels grow and leak fluid under the macula, the part of your eye responsible for sharp, central vision. This can cause blurred vision or blind spots.

What is faricimab?

Faricimab is a new medicine designed to stop the abnormal blood vessels from leaking, aiming to protect and potentially improve your vision in people with 'wet' AMD.

Hur ges behandlingen?

Faricimab is given as an injection directly into the eye (an intravitreal injection) by an eye specialist.

Hur länge kommer studien att pågå?

The study is planned to last for 100 weeks, which is nearly two years.

Can I still participate if I've had previous eye injections for my AMD?

Generally, no. This study is for people who haven't had previous treatment for their 'wet' AMD in the eye being studied.

Hur du får reda på mer

Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.

Diskussion

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