Faricimab for Diabetic Macular Edema

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Diabetic Macular EdemaFaricimab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Up to 2 years

Year 2
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
Up to 2 years
Incidence and Severity of Ocular Adverse Events
Incidence and Severity of Systemic (Non-Ocular) Adverse Events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

A: Faricimab 6 mg Q8W
19%Cataract
9%Nasopharyngitis
8%Conjunctival haemorrhage
7%Hypertension
6%Diabetic retinal oedema
6%Vitreous detachment
5%Vitreous floaters
5%Fall
5%Intraocular pressure increased
4%Urinary tract infection
3%Pneumonia
2%Sepsis
2%Renal failure
2%Acute myocardial infarction
2%Cardiac failure congestive
2%COVID-19
1%Syncope
1%Pleural effusion
1%Hyperkalaemia
1%Death
1%Chest pain
1%Vitreous haemorrhage
1%Cerebral infarction
1%Cerebrovascular accident
1%Myocardial infarction
1%Atrial fibrillation
1%Acute kidney injury
1%Chronic kidney disease
1%End stage renal disease
1%Acute respiratory failure
1%Osteomyelitis
1%Diabetes mellitus
1%Hyperglycaemia
1%Ischaemic stroke
1%Myocardial ischaemia
1%Cardiac arrest
1%Coronary artery disease
1%Glaucoma
1%Cellulitis
1%Diabetic retinopathy
1%Pulmonary embolism
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03622580) in the A: Faricimab 6 mg Q8W ARM group. Side effects include: Cataract with 19%, Nasopharyngitis with 9%, Conjunctival haemorrhage with 8%, Hypertension with 7%, Diabetic retinal oedema with 6%.

Trial Design

1 Treatment Group

Faricimab PTI
1 of 1

Experimental Treatment

1479 Total Participants · 1 Treatment Group

Primary Treatment: Faricimab · No Placebo Group · Phase 3

Faricimab PTIExperimental Group · 2 Interventions: Faricimab, Sham Procedure · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Faricimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,361 Previous Clinical Trials
1,066,604 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,148 Previous Clinical Trials
874,694 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to comply with the study protocol.
You have completed the study or study drug discontinuation.
You are of childbearing potential and agree to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment.