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ELEVATUM: A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

Sponsor
Genentech, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05224102
Collaborator
(none)
120
Enrollment
37
Locations
1
Arm
24.9
Anticipated Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 4 study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IV, Multicenter, Open-Label, Single-Arm Study to Investigate Faricimab (RO6867461) Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema
Actual Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Mar 28, 2024
Anticipated Study Completion Date :
Mar 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Faricimab

Drug: Faricimab
Participants will receive 6-milligram (mg) intravitreal (IVT) faricimab injections once every 4 weeks (Q4W) up to Week 20, followed by 6-mg IVT faricimab injections once every 8 weeks (Q8W) up to Week 52. Participants will return for the Week 56 safety follow-up visit after ≥28 days following their last study treatment.
Other Names:
  • VABYSMO™
  • RO6867461
  • RG7716

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Best Corrected Visual Acuity (BCVA) from Baseline at Week 56, as Measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters [From Baseline to Week 56]

    Secondary Outcome Measures

    1. Percentage of Participants with a Greater Than or Equal to (≥)2-Step ETDRS Diabetic Retinopathy Severity Scale (DRSS) Improvement from Baseline Over Time [Baseline and Weeks 20 and 56]

    2. Percentage of Participants with a ≥3-Step ETDRS Diabetic Retinopathy Severity Scale (DRSS) Improvement from Baseline Over Time [Baseline and Weeks 20 and 56]

    3. Percentage of Participants with Absence of Intraretinal Fluid Over Time [Baseline and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56]

    4. Percentage of Participants with Absence of Subretinal Fluid Over Time [Baseline and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56]

    5. Change from Baseline in Central Subfield Thickness Over Time [Baseline and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56]

    6. Percentage of Participants Gaining ≥15 or ≥10 Letters in BCVA from Baseline at Week 56 [Baseline and Week 56]

    7. Percentage of Participants Avoiding a Loss of ≥15 or ≥10 Letters in BCVA from Baseline at Week 56 [Baseline and Week 56]

    8. Incidence and Severity of Ocular Adverse Events [From Baseline up to Week 56]

    9. Incidence and Severity of Non-Ocular Adverse Events [From Baseline up to Week 56]

    10. Number of Participants Testing Positive for Anti-Drug Antibodies (ADAs) Against Faricimab at Baseline and Anytime During the Study [From Baseline up to Week 56]

    Eligibility Criteria

    Criteria

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

    • Self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander

    • Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association, and current regular use of insulin or other injectable drugs (e.g., dulaglutide and liraglutide) and/or oral anti-hyperglycemic agents for the treatment of diabetes

    • Hemoglobin A1c (HbA1c) ≤10% (Note: up to 20% of participants enrolled may have HbA1c up to 12%)

    • For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraception methods as defined in the protocol

    Ocular Inclusion Criteria for Study Eye:

    • Intravitreal (IVT) treatment-naïve in the study eye (i.e., have not received previous treatment with any anti-VEGF IVT or any corticosteroids periocular or IVT in the study eye)

    • Diabetic macular edema, defined as macular thickening by SD-OCT involving the center of the macula

    • BCVA letter score of 73 to 20 letters (both inclusive) using the ETDRS protocol at the initial testing distance of 4 meters at the baseline visit (Day 1)

    • Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis

    Exclusion Criteria:
    General Exclusion Criteria:

    • Diabetes mellitus (type 1 or type 2) that is currently medically untreated

    • Previously untreated diabetes mellitus (type 1 or type 2) who started on 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

    • Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used by the patient during the study

    • History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, or 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 (cerebral vascular accident) or myocardial infarction within 12 months prior to Day 1

    • Any febrile illness within 1 week prior to Day 1

    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab

    • Uncontrolled blood pressure, defined as systolic >180 mmHg and/or diastolic >100 mmHg (while patient is at rest in a sitting position); if a patient's initial reading exceeds these values, a second reading may be taken ≥30 minutes later on the same day

    • 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 inflammatory biomarkers

    • Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins or minerals) within 3 months (or 5 half-lives, whichever is longer) prior to Day 1, or during the course of this study

    • Substance abuse occurring within 12 months prior to screening, in the investigator's judgment

    • Use of systemic immunomodulatory treatments (e.g., IL-6 inhibitors) within 6 months or 5 half-lives (whichever is longer) prior to Day 1

    • Use of any systemic corticosteroids within 1 month prior to Day 1

    • Systemic treatment for suspected or active systemic infection

    • Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives (whichever is longer) prior to Day 1

    • Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, or ethambutol) during the 6-months (or 5 half-lives, whichever is longer) prior to Day 1

    • Receiving any treatment that leads to immunosuppression within 6 months (or 5 half-lives, whichever is longer) prior to Day 1

    • Requiring continuous use of any medications or treatments listed as prohibited therapy

    Ocular Exclusion Criteria for Study Eye:

    • High-risk proliferative diabetic retinopathy (PDR) in the study eye, using any of the following established criteria for high-risk PDR: Any vitreous or pre-retinal hemorrhage; Neovascularization elsewhere ≥1/2 disc area within an area equivalent to the mydriatic ETDRS 7 fields on clinical examination or on CFPs; Neovascularization at disc ≥1/3 disc area on clinical examination

    • Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye, as evaluated by the central reading center

    • Any history of or ongoing rubeosis iridis

    • Any panretinal photocoagulation or macular laser (focal, grid or micropulse) photocoagulation treatment received in the study eye prior Day 1

    • Any history of treatment with anti-VEGF or any periocular or IVT corticosteroids in the study eye prior to Day 1

    • Any treatment for dry eye disease in the last month prior to Day 1 (e.g., cyclosporine eye drops, lifitegrast eye drops). Lubricating eye drops and ointments are permitted.

    • Any treatment with anti-inflammatory eye drops (e.g., doxycycline) within 1 month prior to Day 1

    • Any intraocular surgery (e.g., cataract surgery) within 3 months prior to Day 1 or any planned surgery during the study

    • Any glaucoma surgery prior to the screening visit

    • History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy

    • Uncontrolled glaucoma

    • Any active or suspected ocular or periocular infections on Day 1

    • Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature [SUN] criteria >0 or National Eye Institute [NEI] vitreous haze grading >0) or any history of intraocular inflammation

    • Any history of idiopathic, infectious, or noninfectious uveitis

    • Any current ocular condition or other causes of visual impairment for which, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema

    Ocular Exclusion Criteria for Non-Study Eye:

    • Any history of idiopathic or immune-mediated uveitis

    • Active ocular inflammation or suspected or active ocular or periocular infection on Day 1

    • Currently receiving treatment with brolucizumab or bevacizumab in the non-study eye and is unwilling to switch to a protocol-allowed, non-study eye anti-VEGF treatment during the study

    • Any previous treatment with Iluvien® or Retisert® (fluocinolone acetonide IVT implant) in the non-study eye

    • Non-functioning non-study eye, defined as either: BCVA of hand motion or worse; No physical presence of non-study eye (i.e., monocular); or, Legally blind in the patient's relevant jurisdiction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barnet Dulaney Perkins Eye Center Mesa Arizona United States 85206
    2 Win Retina Arcadia California United States 91006
    3 Retinal Diagnostic Center Campbell California United States 95008
    4 The Retina Partners Encino California United States 91436
    5 Retina Consultants of Orange County Fullerton California United States 92835
    6 Kaiser Permanente Southern California Riverside California United States 92505
    7 Retinal Consultants Medical Group Sacramento California United States 95825
    8 Southwest Retina Consultants Durango Colorado United States 81303
    9 Emerson Clinical Research Institute LLC Washington District of Columbia United States 20011-3010
    10 Blue Ocean Clinical Research Clearwater Florida United States 33761-2046
    11 Retina Macula Specialists of Miami - LeJeune Road Office Miami Florida United States 33126-5690
    12 Florida Retina Institute Orlando Florida United States 32806-1101
    13 Fort Lauderdale Eye Institute Plantation Florida United States 33324
    14 University Retina and Macula Associates, PC Lemont Illinois United States 60439
    15 Wilmer Eye Institute Johns Hopkins University Baltimore Maryland United States 21287-0005
    16 Md Medical Research Oxon Hill Maryland United States 20745
    17 Retina Associates of Michigan Grand Blanc Michigan United States 48439-8301
    18 Retina Consultants of Nevada Las Vegas Nevada United States 89123
    19 The Retina Center of New Jersey Bloomfield New Jersey United States 07003-3000
    20 NJ Retina-Teaneck (Clinic) Teaneck New Jersey United States 07666-1704
    21 Carolina Eye Associates Southern Pines North Carolina United States 28387
    22 Piedmont Retina Specialists Winston-Salem North Carolina United States 27103-6970
    23 Retina Associates of Cleveland, INC Beachwood Ohio United States 44122-7340
    24 Retina Associates of Cleveland - Middleburg Heights Location Middleburg Heights Ohio United States 44130
    25 Wills Eye Hospital; Neuro-Ophthalmology Service Philadelphia Pennsylvania United States 19107-5109
    26 Black Hills Eye Institute Rapid City South Dakota United States 57701
    27 Charles Retina Institute Memphis Tennessee United States 38119
    28 Austin Clinical Research LLC Austin Texas United States 78750
    29 Houston Eye Associates Houston Texas United States 77025-1756
    30 Retina & Vitreous of Texas Houston Texas United States 77025
    31 Macula Vitreous Retina Physicians and Surgeons Houston Texas United States 77030
    32 Brown Retina Institute San Antonio Texas United States 78251-4551
    33 Retina Center of Texas Southlake Texas United States 76092
    34 Strategic Clinical Research Group, LLC Willow Park Texas United States 76087
    35 Piedmont Eye Center Lynchburg Virginia United States 24502
    36 Wagner Macula & Retina Center Norfolk Virginia United States 23502
    37 Emanuelli Research and Development Center LLC Arecibo Puerto Rico 00612

    Sponsors and Collaborators

    • Genentech, Inc.

    Investigators

    • Study Director: Clinical Trials, Genentech, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT05224102
    Other Study ID Numbers:
    • ML43435
    First Posted:
    Feb 4, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Macular Edema
    Edema

    Study Results

    No Results Posted as of Aug 22, 2022