Faricimab for Diabetic Macular Edema (ELEVATUM Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Genentech, Inc.
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This 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; in addition, a cohort of Asian Indian participants will be enrolled in India.
What safety data is available for Faricimab in treating diabetic macular edema?Faricimab, also known as Vabysmo, has undergone several clinical trials to assess its safety in treating diabetic macular edema (DME). The Phase III YOSEMITE and RHINE trials, as well as the BOULEVARD trial, evaluated its safety profile. These studies demonstrated that Faricimab has a good safety profile, with results comparable to other treatments like ranibizumab and aflibercept. The trials showed that Faricimab is effective in improving visual acuity and reducing central retinal thickness, with a safety profile consistent with existing treatments for DME.13567
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are using certain systemic medications, like systemic corticosteroids or immunomodulatory treatments, within specific time frames before the trial starts. It's best to discuss your current medications with the trial team to see if they are allowed.
Is the drug Faricimab a promising treatment for Diabetic Macular Edema?Yes, Faricimab is a promising treatment for Diabetic Macular Edema. It has shown excellent results in improving vision and reducing the need for frequent injections. It targets two key factors involved in the disease, which helps in maintaining vision and reducing eye swelling. Clinical trials have demonstrated its effectiveness and potential for long-term use.12356
What data supports the idea that Faricimab for Diabetic Macular Edema is an effective drug?The available research shows that Faricimab is effective for treating Diabetic Macular Edema. It has been approved in the USA and Japan for this condition, indicating its effectiveness. The YOSEMITE and RHINE trials, which are phase III studies, have shown positive results in terms of efficacy and safety for patients with Diabetic Macular Edema. Additionally, Faricimab has been effective in patients who did not respond well to another treatment called Aflibercept, suggesting it can be a good alternative for those cases.13467
Eligibility Criteria
This trial is for treatment-naive adults with diabetic macular edema who identify as Black/African American, Hispanic/Latino American, Native American/Alaska Native/Native Hawaiian/Pacific Islander, or Asian Indian. Participants must have a specific level of vision impairment and controlled diabetes. Pregnant women and those with recent serious cardiovascular events or untreated diabetes are excluded.Inclusion Criteria
I have diabetes and am currently using insulin or other diabetes medications.
Exclusion Criteria
My eyes have specific conditions or have received certain treatments as listed.
I haven't taken any medication recently known to harm my organs.
I have diabetes (type 1 or 2) and am not taking medication for it.
Treatment Details
The study tests Faricimab's effectiveness in underrepresented populations with diabetic macular edema. It focuses on patients without prior treatments for this condition to see how they respond to the medication.
2Treatment groups
Experimental Treatment
Group I: Main Phase: FaricimabExperimental Treatment1 Intervention
Participants in the main study phase will receive 6-milligram (mg) faricimab intravitreal (IVT) 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.
Group II: Long-Term Extension Phase: FaricimabExperimental Treatment1 Intervention
Eligible participants in the U.S. who opt to continue into the long-term extension (LTE) phase of this study will receive 6-mg faricimab IVT injections according to the personalized treatment interval (PTI) dosing algorithm. The minimum and maximum PTIs in the LTE are Q4W and once every 24 weeks (Q24W), respectively.
Faricimab is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Vabysmo for:
- Neovascular age-related macular degeneration (nAMD)
- Diabetic macular edema (DME)
- Macular edema following retinal vein occlusion (RVO)
🇪🇺 Approved in European Union as Vabysmo for:
- Neovascular age-related macular degeneration (nAMD)
- Diabetic macular edema (DME)
🇨🇦 Approved in Canada as Vabysmo for:
- Neovascular age-related macular degeneration (nAMD)
- Diabetic macular edema (DME)
Find a clinic near you
Research locations nearbySelect from list below to view details:
NJ Retina-Toms RiverToms River, NJ
Retina Center of TexasSouthlake, TX
Retina Associates of Cleveland, INCBeachwood, OH
NJ Retina - TeaneckTeaneck, NJ
More Trial Locations
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Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
References
Faricimab: First Approval. [2022]Faricimab (faricimab-svoa; Vabysmo™) is a bispecific antibody that binds to and inhibits both vascular endothelial growth factor (VEGF)-A and angiopoietin-2 (Ang-2). Administered by intravitreal injection, faricimab is being developed by Roche/Genentech for use in the treatment of retinal vascular diseases. In January 2022 faricimab received its first approvals, in the USA, for use in the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) or diabetic macular edema (DME). Faricimab has also recently been approved in Japan, and is currently under regulatory review in the EU, for use in nAMD and DME. Phase III clinical development of faricimab for use in the treatment of nAMD, DME, and macular edema due to retinal vein occlusion is continuing in multiple other countries worldwide. This article summarizes the milestones in the development of faricimab leading to these first approvals for nAMD and DME in the USA.
YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. [2022]Faricimab is a novel anti-angiopoietin-2 and anti-vascular endothelial growth factor (VEGF) bispecific antibody with high affinities and specificities for both VEGF and angiopoietin-2. It is postulated that targeting angiogenic factors and inflammatory pathways in addition to the VEGF pathway will increase treatment durability and improve outcomes. The phase 3 YOSEMITE (ClinicalTrials.gov identifier, NCT03622580) and RHINE (ClinicalTrials.gov identifier, NCT03622593) trials are designed to assess efficacy, safety, and durability of faricimab compared with aflibercept in patients with diabetic macular edema (DME). The trials evaluate a personalized treatment interval (PTI) approach to address heterogeneity in treatment response among patients with DME.
Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial. [2023]To evaluate efficacy, durability, and safety of faricimab in Japanese patients with diabetic macular edema (DME).
One Year Results of Faricimab for Aflibercept-Resistant Diabetic Macular Edema. [2023]To assess the 12 month outcomes of intravitreal faricimab (IVF) in treatment-resistant diabetic macular edema (DME) recalcitrant to intravitreal aflibercept (IVA).
[Faricimab: from research to clinical practice]. [2023]Development of new molecules for anti-angiogenic therapy pursues the following objectives: to increase the interval between injections, which can reduce the treatment burden; to improve the effectiveness of treatment by affecting various links of pathogenesis; to ensure a good safety profile. Faricimab is a humanized immunoglobulin G antibody that targets two key angiogenesis sites: vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). In the STAIRWAY clinical trial, faricimab was shown to produce similar results to monthly ranibizumab at longer intervals and fewer intravitreal injections in patients with neovascular age-related macular degeneration, specifically in terms of visual preservation and reduction in central retinal thickness (CRT). In the BOULEVARD trial, which lasted 36 weeks, the severity of diabetic retinopathy according to DRSS improved in previously untreated patients with diabetic macular edema by two stages and more in 12.2% of the 0.3 mg ranibizumab group, in 27.7% of patients in the 1.5 mg faricimab group, and in 38.6% of patients in the group treated with 6.0 mg faricimab. In the TENAYA, as well as LUCERNE, YOSEMITE and RHINE trials, the increase in best-corrected visual acuity (BCVA) from baseline in the faricimab group was comparable to that in the aflibercept group. Real clinical practice showed an increase in BCVA from 59.5 to 60.6 letters (p=0.035) due to a decrease in CRT from 334.3 to 303.3 µm (p=0.001). The first published studies are now appearing, and their results correspond to the clinical trials, which indicates a stable effect of the drug and the prospects for use in a large cohort of patients.
BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. [2023]Dual inhibition of angiopoietin-2 and VEGF-A with faricimab (Vabysmo) offers excellent visual acuity gains with strong durability in patients with diabetic macular edema (ME) and neovascular age-related macular degeneration. The phase III BALATON/COMINO (NCT04740905/NCT04740931) trials will investigate the efficacy, safety, and durability of faricimab in patients with ME due to retinal vein occlusion (RVO).
Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials. [2023]To assess the 1-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema from Asian and non-Asian countries.