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Monoclonal Antibodies

Faricimab for Macular Edema (COMINO 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, and 24
Awards & highlights

COMINO Trial Summary

This trial is studying an injection to treat macular edema due to central or hemiretinal vein occlusion. The injection will be given every 4 weeks for 24 weeks, then as needed according to a personalized treatment interval.

Eligible Conditions
  • Macular Edema
  • Central Retinal Vein Occlusion
  • Hemiretinal Vein Occlusion

COMINO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 8, 12, 16, 20, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 8, 12, 16, 20, and 24 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

COMINO 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
Faricimab
2023
Completed Phase 3
~6720
Sham Procedure
2018
Completed Phase 3
~6940

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,088,681 Total Patients Enrolled
15 Trials studying Macular Edema
11,444 Patients Enrolled for Macular Edema
Chugai PharmaceuticalIndustry Sponsor
95 Previous Clinical Trials
20,975 Total Patients Enrolled
1 Trials studying Macular Edema
553 Patients Enrolled for Macular Edema
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,003 Total Patients Enrolled
16 Trials studying Macular Edema
11,251 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.

Does Faricimab carry a high risk for adverse side effects?

"Since this is a phase 3 trial, there is some data supporting efficacy and multiple rounds of data supporting safety, so our team at Power estimates the safety of Faricimab to be a 3."

Answered by AI

How many people can participate in this research project?

"This particular study is no longer enrolling patients. It was originally posted on March 2nd, 2021 but the most recent update was on August 30th, 2022. There are currently 133 other trials looking for macular edema participants and 54 that need individuals with Faricimab experience."

Answered by AI

At how many hospitals is this experiment being conducted?

"This trial has 67 different centres where it is currently being conducted, such as University Retina and Macula Associates, PC in Oak Forest, Retina-Vitreous Associates Medical Group in Beverly Hills, Maine Eye Center in Portland."

Answered by AI

What is the research history of Faricimab?

"Faricimab was first studied in the year 2013 at Massachusetts General Hospital. Since then there have been 253 completed trials, 54 of which are still active. There is a significant amount of research being conducted out of Oak Forest, Illinois."

Answered by AI

What is the typical reason why a doctor would prescribe Faricimab?

"While typically used to help patients with wet age-related macular degeneration (wamd), faricimab can also be employed in the treatment of conditions like macular edema and diabetic macular edema (dme)."

Answered by AI

Are new participants being accepted into this experiment?

"No, this clinical study is not currently looking for more participants. As detailed on clinicaltrials.gov, this research was initially posted on March 2nd 2021 and has since been updated on August 30th 2022. There are 187 other medical trials that patients can participate in."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
New Jersey
South Carolina
What site did they apply to?
Prairie Retina Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Looking for anything that could possible improve my low vision in my affected eye.
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 Central Retinal or Hemiretinal Vein Occlusion
2021. "A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04740931.
~179 spots leftby Apr 2025
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