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Monoclonal Antibodies

Faricimab for Diabetic Macular Edema (ALTIMETER Trial)

Q: Are there any additional investigations being conducted utilizing Faricimab?

Presently, there are five Faricimab trials in progress. 4 of them have advanced to Phase 3 and the majority are situated in Sunderland, <a href="https://www.withpower.com/clinical-trials/tennessee">Tennessee</a>; yet there is a total of 1,076 clinical sites conducting research on this treatment.

Q: Is this experiment pioneering a new therapeutic approach?

At the moment, Faricimab is being tested in 5 active trials across 174 cities and 33 nations. The initial assessment of this medication was carried out by Hoffmann-La Roche and was completed in 2020, with 1479 participants participating. Since then, 8 additional experiments have been conducted.

Q: What is the maximum capacity of individuals allowed in this research endeavor?

At this time, enrollment for this clinical trial is not available. It was initially posted on December 1st 2020 and the details were last updated on November 22nd 2022. Should you wish to pursue other studies, 114 trials are currently recruiting patients with edema while 5 studies related to faricimab have opened their recruitment programs.

Q: Is Faricimab safe for widespread consumption according to medical research?

Our experts at Power assigned Faricimab a score of 2, as the Phase 2 trials only provided evidence for its safety and not efficacy.

Q: Is this research project accepting new participants?

This clinical trial is presently in a dormant state and not actively recruiting. It was initially published on December 1st 2020, with the last update being November 22nd 2022. If you are searching for alternatives, there are currently 114 studies that accept enrolment from edema sufferers while 5 trials are open to Faricimab participants.

Phase 2

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 week 24

Awards & highlights

ALTIMETER Trial Summary

This trial is exploring the effects of a new drug on diabetic macular edema, and how it changes over time.

Eligible Conditions

Diabetic Macular Edema

ALTIMETER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 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

Percentage of Participants With a ≥2-Step Improvement From Baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye at Week 24

Secondary outcome measures

Adjusted Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) in the Study Eye at Week 24

Adjusted Mean Change From Baseline in Central Subfield Thickness in the Study Eye at Week 24

Median Time to First Absence of DME in the Study Eye During the Study

+2 more

Side effects data

From 2021 Phase 3 trial • 940 Patients • NCT03622580

18%

Cataract

12%

Hypertension

11%

Diabetic retinal oedema

10%

Nasopharyngitis

Conjunctival haemorrhage

Urinary tract infection

Vitreous detachment

Intraocular pressure increased

Vitreous floaters

Fall

Pneumonia

Myocardial infarction

Cardiac failure congestive

Osteomyelitis

Sepsis

Chest pain

Coronary artery disease

Cellulitis

Chronic kidney disease

COVID-19

Cerebrovascular accident

Acute kidney injury

Acute respiratory failure

Syncope

Osteoarthritis

Adenocarcinoma of colon

Cellulitis gangrenous

End stage renal disease

Retinal artery occlusion

COVID-19 pneumonia

Gangrene

Anaemia

Acute left ventricular failure

Acute myocardial infarction

Angina pectoris

Diabetic retinopathy

Diabetic foot infection

Ischaemic stroke

Renal failure

Diabetic foot

100%

80%

60%

40%

20%

Study treatment Arm

C: Aflibercept 2 mg Q8W

A: Faricimab 6 mg Q8W

B: Faricimab 6 mg PTI

ALTIMETER Trial Design

1Treatment groups

Experimental Treatment

Group I: FaricimabExperimental Treatment1 Intervention

Participants will receive 6 doses (one 6 mg faricimab intravitreal [IVT] injection every 28 days [Q4W]) starting at Day 1 and ending on the Day 140 visit. Participants will return for a safety follow-up visit (SFV) after ≥28 days and within <35 days following their last study treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Faricimab

2023

Completed Phase 3

~6720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,090,124 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,841 Total Patients Enrolled

Frequently Asked Questions

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

Are there any additional investigations being conducted utilizing Faricimab?

"Presently, there are five Faricimab trials in progress. 4 of them have advanced to Phase 3 and the majority are situated in Sunderland, Tennessee; yet there is a total of 1,076 clinical sites conducting research on this treatment."

Answered by AI

Is this experiment pioneering a new therapeutic approach?

"At the moment, Faricimab is being tested in 5 active trials across 174 cities and 33 nations. The initial assessment of this medication was carried out by Hoffmann-La Roche and was completed in 2020, with 1479 participants participating. Since then, 8 additional experiments have been conducted."

Answered by AI

What is the maximum capacity of individuals allowed in this research endeavor?

"At this time, enrollment for this clinical trial is not available. It was initially posted on December 1st 2020 and the details were last updated on November 22nd 2022. Should you wish to pursue other studies, 114 trials are currently recruiting patients with edema while 5 studies related to faricimab have opened their recruitment programs."

Answered by AI

Is Faricimab safe for widespread consumption according to medical research?

"Our experts at Power assigned Faricimab a score of 2, as the Phase 2 trials only provided evidence for its safety and not efficacy."

Answered by AI

Is this research project accepting new participants?

"This clinical trial is presently in a dormant state and not actively recruiting. It was initially published on December 1st 2020, with the last update being November 22nd 2022. If you are searching for alternatives, there are currently 114 studies that accept enrolment from edema sufferers while 5 trials are open to Faricimab participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab

2020. "A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04597918.