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

NCT04597918 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: MR419262020-001174-30
• Study Type: interventional
• Target: 99
• Locations: 7 countries
• Sites: 23

Brief Summary

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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

  The ETDRS DRSS score of each participant's study eye was assessed using ultra-wide field color fundus photography (UWF-CFP) taken by trained personnel at the study sites. Analysis of the fundus photographs was performed by the central reading center, and the percentage of participants with a ≥2-step improvement from baseline was summarized along with a two-sided 95% Clopper-Pearson exact confidence interval. Baseline was defined as the participant's last observation prior to initiation of study drug.

  Baseline and Week 24

Secondary Outcomes (5)

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

  From Baseline to Week 24

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

  From Baseline to Week 24

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

  From Baseline to Week 24

• Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Week 24

  Week 24

• Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Week 24

  Week 24

Study Arms (1)

Faricimab

EXPERIMENTAL

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.

Drug: Faricimab

Interventions

Faricimab DRUG

A 6-milligram (mg) dose of faricimab will be administered intravitreally (IVT) in the study eye once every 4 weeks (Q4W).

Also known as: VABYSMO™, RO6867461, RG7716

Faricimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (23)

Bascom Palmer Eye Institute

Naples, Florida, 34103, United States

Location

Northwestern Medical Group/Northwestern University

Chicago, Illinois, 60611, United States

Location

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452, United States

Location

Raj K. Maturi, MD PC

Indianapolis, Indiana, 46290, United States

Location

Cumberland Valley Retina PC

Hagerstown, Maryland, 21740, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Long Is. Vitreoretinal Consult

Hauppauge, New York, 11788, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Retina Res Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Research Center for Retina

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384-4167, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Centro Oftalmológico Dr. Charles S.A.

Capital Federal, C1015ABO, Argentina

Location

Oftalmos

Capital Federal, C1120AAN, Argentina

Location

Vitreous Retina Macula Specialists of Toronto

Etobicoke, Ontario, M8X 2X3, Canada

Location

The Retina Centre of Ottawa

Ottawa, Ontario, K2B 7E9, Canada

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Ospedale San Giuseppe; U.O. Oculistica

Milan, Lombardy, 20123, Italy

Location

Irccs Ospedale San Raffaele;U.O. Oculistica

Milan, Lombardy, 20132, Italy

Location

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy

Warsaw, 04-141, Poland

Location

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, GL1 3NN, United Kingdom

Location

Kings College Hospital

London, SW9 8RR, United Kingdom

Location

Sunderland Eye Infirmary

Sunderland, SR2 9HP, United Kingdom

Location

MeSH Terms

Interventions

faricimab

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 22, 2020
• Study Start: November 25, 2020
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

AR (2); CA (2); PL (1); DE (1); IT (2); GB (3); US (12)