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Monoclonal Antibodies
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion (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
No Placebo-Only Group
Pivotal 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
- Cystoid Macular Edema
- Macular Edema
- Branch Retinal Vein Occlusion
Timeline
Screening ~ 3 weeks3 visits
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
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24
Secondary study objectives
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
Incidence of Non-Ocular Adverse Events
Incidence of Ocular Adverse Events in the Fellow Eye
+42 moreSide effects data
From 2023 Phase 3 trial • 1479 Patients • NCT0443283113%
COVID-19
11%
Cataract
4%
Hypertension
4%
Diabetic retinal oedema
4%
Nasopharyngitis
3%
Urinary tract infection
3%
Conjunctival haemorrhage
3%
Vitreous floaters
3%
Diabetic retinopathy
3%
Vitreous detachment
3%
Intraocular pressure increased
3%
Posterior capsule opacification
2%
Myocardial infarction
2%
Acute kidney injury
1%
Cardiac failure congestive
1%
COVID-19 pneumonia
1%
Osteomyelitis
1%
Pneumonia
1%
Localised infection
1%
Skin ulcer
1%
Death
1%
Coronary artery disease
1%
Cellulitis
1%
Sepsis
1%
Cerebrovascular accident
1%
Renal failure
1%
Vitreous haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Faricimab PTI (Prior Faricimab Q8W)
Faricimab PTI (Prior Aflibercept Q8W)
Faricimab PTI (Prior Faricimab PTI)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~6420
Faricimab
2023
Completed Phase 3
~7760
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,460 Previous Clinical Trials
1,097,346 Total Patients Enrolled
Chugai PharmaceuticalIndustry Sponsor
98 Previous Clinical Trials
22,035 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,230 Previous Clinical Trials
896,701 Total Patients Enrolled