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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04597918
Collaborator
(none)
99
Enrollment
28
Locations
1
Arm
24.9
Anticipated Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
99 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 28, 2022
Anticipated Study Completion Date :
Dec 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Faricimab

Drug: Faricimab
A 6-milligram (mg) dose of faricimab will be administered intravitreally (IVT) in the study eye once every 4 weeks (Q4W).
Other Names:
  • VABYSMO™
  • RO6867461
  • RG7716

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) at Day 112 [Baseline, Day 112]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 California Retina Consultants Santa Barbara California United States 93103
    2 Bascom Palmer Eye Institute Naples Florida United States 34103
    3 Northwestern Medical Group/Northwestern University Chicago Illinois United States 60611
    4 University Retina and Macula Associates, PC Lemont Illinois United States 60439
    5 Raj K. Maturi, MD PC Indianapolis Indiana United States 46290
    6 Cumberland Valley Retina PC Hagerstown Maryland United States 21740
    7 The Retina Institute Saint Louis Missouri United States 63128
    8 Long Is. Vitreoretinal Consult Great Neck New York United States 11021
    9 Charles Retina Institute Memphis Tennessee United States 38119
    10 Retina Res Institute of Texas Abilene Texas United States 79606
    11 Austin Research Center for Retina Austin Texas United States 78705
    12 Retina Consultants of Texas Bellaire Texas United States 77401
    13 Strategic Clinical Research Group, LLC Willow Park Texas United States 76087
    14 Centro Oftalmológico Dr. Charles S.A. Capital Federal Argentina C1015ABO
    15 Oftalmos Capital Federal Argentina C1120AAN
    16 Vitreous Retina Macula Specialists of Toronto Etobicoke Ontario Canada M8X 2X3
    17 The Retina Centre of Ottawa Ottawa Ontario Canada K2B 7E9
    18 Clinical Hospital Sveti Duh Zagreb Croatia 10000
    19 Universitätsklinikum Freiburg, Klinik für Augenheilkunde Freiburg Germany 79106
    20 Universitätsklinikum Tübingen Tübingen Germany 72076
    21 Ospedale San Giuseppe; U.O. Oculistica Milano Lombardia Italy 20123
    22 Irccs Ospedale San Raffaele;U.O. Oculistica Milano Lombardia Italy 20132
    23 Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica Perugia Umbria Italy 06129
    24 Wojskowy Instytut Medyczny Warszawa Poland 04-141
    25 Gloucestershire Hospitals NHS Foundation Trust Gloucestershire United Kingdom GL1 3NN
    26 Royal Free London NHS Foundation Trust London United Kingdom NW3 2QG
    27 Kings College Hospital London United Kingdom SW9 8RR
    28 Sunderland Eye Infirmary Sunderland United Kingdom SR2 9HP

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04597918
    Other Study ID Numbers:
    • MR41926
    • 2020-001174-30
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Edema
    Edema

    Study Results

    No Results Posted as of Jul 26, 2022