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Monoclonal Antibodies

Faricimab for Diabetic Macular Edema (Rhone-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

Rhone-X Trial Summary

This trial will study the long-term safety of a medication given by injection into the eye, in people who have completed one of two other studies.

Eligible Conditions
  • Diabetic Macular Edema

Rhone-X Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and Severity of Ocular Adverse Events
Incidence and Severity of Systemic (Non-Ocular) Adverse Events
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study

Side effects data

From 2021 Phase 3 trial • 940 Patients • NCT03622580
18%
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

Rhone-X Trial Design

1Treatment groups
Experimental Treatment
Group I: 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
2,432 Previous Clinical Trials
1,088,407 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,124 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the known side effects of Faricimab?

"There is both efficacy and safety data for faricimab from Phase 3 trials, so it received a score of 3."

Answered by AI

Are investigators still seeking participants for this research?

"Unfortunately, this particular trial is no longer looking for new patients as of September 2, 2022. The trial was initially posted on August 5, 2020. If you are interested in other edema studies, there are 116 that are actively recruiting participants. Additionally, there are 5 trials for Faricimab enrolling patients."

Answered by AI

How many people are signing up to be a part of this research?

"Currently, this trial is not recruiting patients. The last update to the posting was on September 2nd, 2022 and it was initially posted on August 5th, 2020. For those looking for other studies, there are 116 clinical trials enrolling patients with edema and 5 clinical trials enrolling patients for Faricimab."

Answered by AI

What other medical research studies have included Faricimab as a treatment?

"At the moment, 5 clinical trials are underway that are focused on Faricimab. Of those 5, 4 are in Phase 3. Even though most of the research is based out of Sunderland, Tennessee, there are 1074 different locations running these sorts of trials."

Answered by AI

Are there different hospitals participating in this experiment within the city limits?

"There are 8 recruiting patients for this study such as West Coast Retina Medical Group in San Francisco, VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota in Edina, and Midwest Vision Research Foundation in Chesterfield,to name a few 8 other locations."

Answered by AI

What is the novelty of this particular research?

"There are 5 ongoing studies for Faricimab in 33 countries and 174 cities. The first trial was completed in 2020 and was sponsored by Hoffmann-La Roche. In total, 1479 patients were involved in the Phase 3 drug approval stage of the study. Since 2020, 25 additional trials have been completed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
2020. "A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04432831.
~311 spots leftby May 2025
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