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Monoclonal Antibodies

Faricimab for Macular Edema (BALATON 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 baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Awards & highlights

BALATON Trial Summary

This trial is testing a new drug for macular edema due to branch retinal vein occlusion (BRVO). The drug will be given by injection every 4 weeks for 24 weeks, then participants will be monitored to see if the drug continues to be effective given at a personalized interval.

Eligible Conditions
  • Macular Edema
  • Branch Retinal Vein Occlusion

BALATON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24
Secondary outcome measures
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale
Incidence and Severity of Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study
+43 more

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

BALATON Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)Experimental Treatment2 Interventions
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Group II: Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)Active Control3 Interventions
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham Procedure
2018
Completed Phase 3
~6940
Faricimab
2023
Completed Phase 3
~6720

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,515 Total Patients Enrolled
15 Trials studying Macular Edema
11,620 Patients Enrolled for Macular Edema
Chugai PharmaceuticalIndustry Sponsor
95 Previous Clinical Trials
21,151 Total Patients Enrolled
1 Trials studying Macular Edema
729 Patients Enrolled for Macular Edema
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,387 Total Patients Enrolled
16 Trials studying Macular Edema
11,427 Patients Enrolled for Macular Edema

Frequently Asked Questions

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

For what purpose is Faricimab most commonly prescribed?

"Faricimab is sometimes used to treat wet age-related macular degeneration. Other potential applications for this medication include macular edema, diabetic macular edema, and general macular degeneration."

Answered by AI

What does the Faricimab research landscape look like?

"Faricimab was first studied in 2013 and has had 252 completed clinical trials since then. Currently, 54 clinical trials are actively recruiting, with a significant presence in Salt Lake City, Utah."

Answered by AI

Could you please tell us about the risks associated with Faricimab?

"Faricimab's safety is based on Phase 3 trial data, and it received a 3 because there is evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Florida
Illinois
Other
How old are they?
18 - 65
What site did they apply to?
California Eye Specialists Medical group Inc.
Fort Lauderdale Eye Institute
Prairie Retina Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I was recently diagnosed. I have low vision in my affected eye and am looking for anything that might improve my vision even marginally.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
2021. "A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04740905.
~135 spots leftby Apr 2025
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