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Monoclonal Antibodies
Faricimab for Age-Related Macular Degeneration (AVONELLE-X Trial)
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
AVONELLE-X Trial Summary
This trial will study the long-term effects of a drug given by injection into the eye for those with age-related macular degeneration.
Who is the study for?
This trial is for adults with neovascular age-related macular degeneration who completed previous Phase III studies (GR40306 or GR40844) without dropping out. Women must use effective contraception and not donate eggs during the study. People can't join if they're pregnant, breastfeeding, plan to become pregnant soon, have other eye diseases or conditions that make faricimab unsafe for them, or are allergic to its components.Check my eligibility
What is being tested?
The trial tests the long-term safety of Faricimab given by injection into the eye at personalized intervals to treat nAMD. A substudy also compares treated eyes with untreated fellow eyes to assess corneal health as required by the FDA.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar treatments include eye irritation or discomfort after injection, increased risk of eye infection, possible allergic reactions, and potential impact on vision.
AVONELLE-X Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Main Study: Incidence and Severity of Ocular Adverse Events
Main Study: Incidence and Severity of Systemic (Non-Ocular) Adverse Events
Main Study: Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
+1 moreSecondary outcome measures
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye
Side effects data
From 2021 Phase 3 trial • 940 Patients • NCT0362258018%
Cataract
12%
Hypertension
11%
Diabetic retinal oedema
10%
Nasopharyngitis
8%
Conjunctival haemorrhage
6%
Urinary tract infection
4%
Vitreous detachment
4%
Intraocular pressure increased
3%
Vitreous floaters
3%
Fall
2%
Pneumonia
2%
Myocardial infarction
2%
Cardiac failure congestive
2%
Osteomyelitis
2%
Sepsis
1%
Chest pain
1%
Coronary artery disease
1%
Cellulitis
1%
Chronic kidney disease
1%
COVID-19
1%
Cerebrovascular accident
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Syncope
1%
Osteoarthritis
1%
Adenocarcinoma of colon
1%
Cellulitis gangrenous
1%
End stage renal disease
1%
Retinal artery occlusion
1%
COVID-19 pneumonia
1%
Gangrene
1%
Anaemia
1%
Acute left ventricular failure
1%
Acute myocardial infarction
1%
Angina pectoris
1%
Diabetic retinopathy
1%
Diabetic foot infection
1%
Ischaemic stroke
1%
Renal failure
1%
Diabetic foot
100%
80%
60%
40%
20%
0%
Study treatment Arm
C: Aflibercept 2 mg Q8W
A: Faricimab 6 mg Q8W
B: Faricimab 6 mg PTI
AVONELLE-X Trial Design
2Treatment groups
Experimental Treatment
Group I: Substudy: Faricimab PTIExperimental Treatment1 Intervention
Group II: Main Study: Faricimab PTIExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Faricimab
2023
Completed Phase 3
~6720
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,018 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,466 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious allergic reaction in the past to a biologic medication or any of the substances used in the study injections or preparations.I am not on any medications that are not allowed in the study.I don't have any health conditions that would make using faricimab unsafe for me.I don't have eye diseases that would make faricimab unsafe for me.
Research Study Groups:
This trial has the following groups:- Group 1: Main Study: Faricimab PTI
- Group 2: Substudy: Faricimab PTI
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Faricimab drug been cleared by the FDA?
"Faricimab's safety is supported by Phase 3 trial data, and it received a score of 3."
Answered by AI
Are there other examples of Faricimab being used in a research setting?
"Faricimab was first trialled in 2020 at Rabin Medical Centre for Ophthalmology. There have been a total of 25 completed trials since then, with 5 trials still active. McAllen, Tennessee has a significant number of these ongoing studies."
Answered by AI
Has a similar experiment been conducted before?
"Since 2020, Faricimab has been the subject of clinical trials. The first, sponsored by Hoffmann-La Roche, was conducted in 2020 with 1,479 participants. After the initial Phase 3 trial in 2020, the drug was approved. As of now, there are 5 ongoing trials involving Faricimab being conducted in 174 cities across 33 countries."
Answered by AI
Does this study have any more room for research participants?
"Unfortunately, this study is not looking for any more patients at the moment. However, there are other medical trials with open recruitment at this time. According to clinicaltrials.gov, this study was first posted on April 19th, 2021 and was last updated on September 22nd, 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Retinal Consultants Med Group
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I am an 80 year old retired epidemiologist with AMD and want to contribute to research for a cure.
PatientReceived 2+ prior treatments
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