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

Completed · Phase 2

Conditions studied: Diabetic Macular Edema

In brief

This is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, aqueous humor (AH) biomarker patterns, and genetic polymorphisms in participants with diabetic macular edema (DME) who are treated with faricimab.

Key facts

Study ID

NCT04597918

Run by

Hoffmann-La Roche

People needed

99

Starts

2020-11-25

Expected to finish

2022-12-22

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association
• Hemoglobin A1c (HbA1c) ≤10%
• Patients who are intravitreal (IVT) treatment-naïve in the study eye
• Diabetic macular edema (DME) defined as macular thickening by spectral-domain optical coherence tomography (SD-OCT) involving the center of the macula. This inclusion criterion is to be assessed by the central reading center (CRC).
• Decreased visual acuity (VA) attributable primarily to DME
• Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis

You may not qualify if…

• Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
• Any known hypersensitivity to any of the components in the faricimab injection, dilating eye drops, or any of the anesthetics and antimicrobial preparations used by the patient during the study
• Any major illness or major surgical procedure within 1 month before the Day 1. One re-screening for this criterion is permitted
• History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the faricimab or that might affect interpretation of the results of the study or renders the patient at high-risk for treatment complications, in the opinion of the Investigator
• Active cancer within the past 12 months prior to Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤6 and a stable prostate-specific antigen for >12 months
• Stroke or myocardial infarction within 12 months prior to the Day 1. One re-screening for this criterion is permitted
• Any febrile illness within 1 week prior to Day 1. One re-screening for this criterion is permitted
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
• Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 6 months prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
• Any condition resulting in a compromised immune system that is likely to impact the aqueous humor (AH) inflammatory biomarkers.
• Patients who are currently enrolled in or have participated in any other clinical study involving an investigational product or device, or in any other type of medical research, within 3 months or 5 half-lives prior to Day 1 and up to completion of the current study
• Substance abuse occurring within 12 months prior to screening, in the Investigator's judgment
• Use of systemic immunomodulatory treatments within 6 months or 5 half-lives prior to Day 1
• Use of any systemic corticosteroids (including inhaled corticosteroids from inhalers used regularly, e.g., pulmonary disease, asthma, or seasonal allergy) within 1 month prior to Day 1
• Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives prior to Day 1
• Use of systemic medications known to be toxic to the lens, retina or optic nerve used during the 6-month period or 5 half-lives prior to Day 1 or likely need to be used
• Received a blood transfusion within 3 months prior to the screening visit
• Received any treatment that leads to immunosuppression within 6 months or 5 half-lives prior to Day 1
• Ocular Exclusion Criteria for Study Eye:
• High-risk PDR. This exclusion criterion is to be assessed by the CRC
• Any history of or ongoing rubeosis iridis
• Any panretinal photocoagulation or macular laser photocoagulation treatment received in the study eye prior to the screening visit or expected to be received between the screening visit and Day 1
• Any history of treatment with anti-VEGF or any periocular or IVT corticosteroids in the study eye and no such treatment planned for the time between screening and Day 1
• Any treatment for dry eye disease in the last month prior to Day 1. Lubricating eye drops and ointments are permitted.
• Any treatment with anti-inflammatory eye drops within 1 month prior to Day 1

Where it is running

• Bascom Palmer Eye Institute — Naples, Florida, United States
• Northwestern Medical Group/Northwestern University — Chicago, Illinois, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Raj K. Maturi, MD PC — Indianapolis, Indiana, United States
• Cumberland Valley Retina PC — Hagerstown, Maryland, United States
• The Retina Institute — St Louis, Missouri, United States
• Long Is. Vitreoretinal Consult — Great Neck, New York, United States
• Charles Retina Institute — Germantown, Tennessee, United States
• Retina Res Institute of Texas — Abilene, Texas, United States
• Austin Research Center for Retina — Austin, Texas, United States
• Retina Consultants of Texas — Houston, Texas, United States
• Strategic Clinical Research Group, LLC — Willow Park, Texas, United States
• Centro Oftalmologico Dr. Charles S.A. — Capital Federal, Argentina
• Oftalmos — Capital Federal, Argentina
• Vitreous Retina Macula Specialists of Toronto — Etobicoke, Ontario, Canada
• Retina Institute of Ottawa — Ottawa, Ontario, Canada
• Universitatsklinikum Tubingen — Tübingen, Germany
• Ospedale San Giuseppe — Milan, Lombardy, Italy
• Irccs Ospedale San Raffaele — Milan, Lombardy, Italy
• Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy — Warsaw, Poland
• Gloucestershire Hospitals NHS Foundation Trust — Gloucestershire, United Kingdom
• Kings College Hospital — London, United Kingdom
• Sunderland Eye Infirmary — Sunderland, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.