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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT04597918

Public ClinicalTrials.gov record NCT04597918. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 12:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Exploratory, Prospective, Multi-Center, Open-Label, Single-Arm, Interventional, Phase IIB Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Patients With Diabetic Macular Edema Treated With Faricimab (RO6867461) - ALTIMETER STUDY

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04597918
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
99 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 24, 2020
Primary completion
Dec 21, 2022
Completion
Dec 21, 2022
Last update posted
Jun 14, 2026

2020 – 2022

United States locations

U.S. sites
12
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
Bascom Palmer Eye Institute Naples Florida 34103
Northwestern Medical Group/Northwestern University Chicago Illinois 60611
University Retina and Macula Associates, PC Oak Forest Illinois 60452
Raj K. Maturi, MD PC Indianapolis Indiana 46290
Cumberland Valley Retina PC Hagerstown Maryland 21740
The Retina Institute St Louis Missouri 63128
Long Is. Vitreoretinal Consult Great Neck New York 11021
Charles Retina Institute Germantown Tennessee 38138
Retina Res Institute of Texas Abilene Texas 79606
Austin Research Center for Retina Austin Texas 78705
Retina Consultants of Texas Houston Texas 77030
Strategic Clinical Research Group, LLC Willow Park Texas 76087

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04597918, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 14, 2026 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04597918 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →