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Diabetic Macular EdemaPhase 2ALTIMETERNCT04597918

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

A Phase 2 study testing Faricimab in people with Diabetic Macular Edema, run by Hoffmann-La Roche at 23 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Faricimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
23 sitesin 7 countries
Study dates
25 Nov 2020to 22 Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 37Show fewer
  • 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
  • Any intraocular surgery within 3 months prior to Day 1 or any planned surgery during the study
  • Any glaucoma surgery/laser procedure involving the iris, trabecular meshwork, or ciliary body prior to the screening visit. Only iris surgery/laser might be allowed if they occurred more than 6 months prior to Day 1.
  • History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy
  • Any active or suspected ocular or periocular infections on Day 1
  • Any presence of active intraocular inflammation on Day 1 or any history of intraocular inflammation
  • Any history of idiopathic, infectious, or noninfectious uveitis
  • Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
  • Any current ocular condition or other causes of visual impairment for which, in the opinion of the Investigator, VA loss would not improve from resolution of macular edema
  • Ocular Exclusion Criteria for Fellow Eye:
  • Patient is currently receiving treatment with brolucizumab or bevacizumab in the non-study eye and is unwilling to switch to a protocol allowed non-study eye treatment during the study
  • Any previous treatment with Iluvien® or Retisert® in the non-study eye
  • Non-functioning non-study eye

Trial locations and contacts

23 sites in 7 countries.

23 sites in 7 countries

United States12 sites

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Northwestern Medical Group/Northwestern University

    Chicago, Illinois, 60611

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Long Is. Vitreoretinal Consult

    Great Neck, New York, 11021

  • Cumberland Valley Retina PC

    Hagerstown, Maryland, 21740

  • Retina Consultants of Texas

    Houston, Texas, 77030

  • Raj K. Maturi, MD PC

    Indianapolis, Indiana, 46290

  • Bascom Palmer Eye Institute

    Naples, Florida, 34103

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • The Retina Institute

    St Louis, Missouri, 63128

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

Other trials in United States

United Kingdom3 sites

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL1 3NN

  • Kings College Hospital

    London, SE5 9RS

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP

Other trials in United Kingdom

Argentina2 sites

  • Centro Oftalmologico Dr. Charles S.A.

    Capital Federal, C1116

  • Oftalmos

    Capital Federal, C1120AAN

Other trials in Argentina

Canada2 sites

  • Vitreous Retina Macula Specialists of Toronto

    Etobicoke, Ontario, M8X 2X3

  • Retina Institute of Ottawa

    Ottawa, Ontario, K2B 7E9

Other trials in Canada

Italy2 sites

  • Ospedale San Giuseppe

    Milan, Lombardy, 20123

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132

Other trials in Italy

Germany1 site

  • Universitatsklinikum Tubingen

    Tübingen, 72076

Other trials in Germany

Poland1 site

  • Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy

    Warsaw, 04-141

Other trials in Poland

About this study

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

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.

Being tested
Faricimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaricimabDrug

    Also called VABYSMO™, RO6867461, RG7716

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

Study groups in NCT04597918
Study groupRoleWhat they receive
FaricimabExperimentalParticipants 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.
Receives: Drug: Faricimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 24

Secondary outcomes (5)

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

    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for visit, age (continuous), baseline BCVA (continuous), and region (US and Canada and the rest of the world). An unstructured covariance structure was used. In case of convergence issues with the model, an AR (1) covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM.

    Measured: From Baseline to Week 24

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

    Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using Spectral Domain-Optical Coherence Tomography (SD-OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model was adjusted for visit, age (continuous), baseline CST (continuous), and region (US and Canada and the rest of the world). An unstructured covariance structure was used. In case of convergence issues with the model, an AR (1) covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM.

    Measured: From Baseline to Week 24

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

    An event was defined as the first absence of diabetic macular edema (DME) in the study eye, defined as first time reaching central subfield thickness (CST; ILM-RPE) <305 microns, after baseline. Baseline was defined as the participant's last observation prior to initiation of study drug. The time to first absence of DME was a Kaplan-Meier estimate. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley. Participants without an event and discontinued from treatment were censored at the last CST assessment.

    Measured: From Baseline to Week 24

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

    The absence of intraretinal fluid (IRF) in the study eye (defined as IRF absent or definite outside center subfield only) was assessed by the central reading center using Spectral Domain-Optical Coherence Tomography (SD-OCT). The percentage of participants with absence of IRF and a two-sided 95% Clopper-Pearson exact confidence interval are reported.

    Measured: Week 24

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

    The absence of subretinal fluid (SRF) in the study eye (defined as SRF absent or definite outside center subfield only) was assessed by the central reading center using Spectral Domain-Optical Coherence Tomography (SD-OCT). The percentage of participants with absence of SRF and a two-sided 95% Clopper-Pearson exact confidence interval are reported.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start25 Nov 2020
  3. Primary completion22 Dec 2022
  4. Study completion22 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04597918
Sponsor's protocol ID
MR41926
Other IDs
2020-001174-30
Acronym
ALTIMETER
Status last verified
May 2026
First submitted
19 Oct 2020
Last updated
15 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing).

Publications

  • Schlottmann PG, Fawzi AA, Amador M, Dieckmann A, Gibson K, Glittenberg C, Jhaveri C, Kotak A, Mar F, Neubert A, Sheth VS, Souverain A, Titz B, Vazquez-Lombardi C, Wykoff CC, Ziemssen F, Vujosevic S. Aqueous Humor Biomarkers, Efficacy, and Safety in Patients with Naive Diabetic Macular Edema Treated with Faricimab: The ALTIMETER Study. Ophthalmol Sci. 2026 Feb 26;6(5):101129. doi: 10.1016/j.xops.2026.101129. eCollection 2026 May.

    PubMed 42058170

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Faricimab in people with Diabetic Macular Edema, run by Hoffmann-La Roche at 23 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, United Kingdom, Argentina, Canada, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04597918, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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