Faricimab for Diabetic Macular Edema
(INSITE-DME Trial)
Recruiting in Palo Alto (17 mi)
+49 other locations
Overseen byDr. Varun Chaudhary, MD, FRCS(C)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: McMaster University
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, there is a 12-week washout period required for previous anti-VEGF treatments before starting the trial.
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, especially in patients who did not respond well to other treatments like ranibizumab or aflibercept. In one study, patients who switched to Faricimab had their treatment intervals extended from about 6 weeks to nearly 11 weeks, meaning they needed fewer injections. Additionally, Faricimab has been approved in the USA and Japan for treating this condition, indicating its effectiveness and safety.
12345What safety data is available for Faricimab in treating Diabetic Macular Edema?
The provided research does not contain any safety data related to Faricimab or its other names (Vabysmo, Faricimab-svoa, RG 7716, RO 6867461, Faricimab Injection). The studies focus on other medications and conditions, primarily related to COPD treatments.
678910Is 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 works by targeting two key factors involved in the disease, leading to better outcomes for patients, even those who did not respond well to other treatments.
124511Eligibility Criteria
Adults over 18 with diabetes (type 1 or type 2) and diabetic macular edema affecting the central vision, who have a certain level of visual impairment. Participants must have stable blood sugar control with an HbA1c under 10%. They should not have had recent eye surgery, ocular inflammation, infections, uncontrolled glaucoma, or previous treatments that could affect the trial's outcome.Inclusion Criteria
Hemoglobin A1c must be <10% within 2 months prior to 1st study treatment
I am 18 years old or older.
My eye scan shows swelling in the center due to diabetes.
+4 more
Exclusion Criteria
Anticipated problems, in the judgment of the site investigator, maintaining compliance with the protocol, including attending study visits, completing assessments or procedures
My eye swelling is not due to diabetic macular edema.
Known hypersensitivity to faricimab or any of the excipients in the faricimab injection
+19 more
Participant Groups
The study is testing Faricimab for diabetic macular edema by comparing two approaches: 'treat & extend' where treatment intervals may be adjusted based on disease activity versus a fixed schedule of doses regardless of changes in symptoms.
2Treatment groups
Experimental Treatment
Group I: Treat and ExtendExperimental Treatment1 Intervention
Participants randomized to the T\&E Arm will initially receive 6 milligrams (mg) faricimab intravitreal (IVT) injections monthly (28d +/-7 days), with treatment intervals increased/extended, reduced, or maintained based on CST assessments, until week 100.
Group II: Control/Usual Care ArmExperimental Treatment1 Intervention
Participants in the control arm will receive 6 milligrams (mg) faricimab intravitreal (IVT) injections monthly (28d +/-7 days), for 6 treatments. Afterwards, participants will continue to receive 6mg faricimab IVT every 8 weeks until week 100.
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:
Calgary Retina ConsultantsCalgary, Canada
Vitreous Retina Macula Specialists of TorontoToronto, Canada
Retina & Vitreous of TexasBellaire, TX
Mississippi Retina AssociatesJackson, MS
More Trial Locations
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Who Is Running the Clinical Trial?
McMaster UniversityLead Sponsor
Hoffmann-La RocheIndustry Sponsor
References
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).
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.
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).
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).
Faricimab for Diabetic Macular Edema in Patients Refractory to Ranibizumab or Aflibercept. [2023]Background and Objectives: Faricimab is the first intravitreal injection of vascular endothelial growth factor-A and angiopoietin-2 bispecific monoclonal antibody. Here, we evaluate the functional and anatomical outcomes of faricimab treatment in patients with diabetic macular edema (DME) that was refractory to ranibizumab or aflibercept. Materials and Methods: We performed a retrospective, observational, consecutive-case study of patients who had DME that was refractory to treatment with ranibizumab or aflibercept and were treated with faricimab between July 2022 and January 2023 under a pro re nata regimen. All the participants were followed for ≥4 months after the initiation of faricimab. The primary outcome was a recurrence interval of ≥12 weeks, and the secondary outcomes were the changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). Results: We analyzed 18 eyes of 18 patients. The mean recurrence interval of previous anti-VEGF injection was 5.8 ± 2.5 weeks, which was significantly extended to 10.8 ± 4.9 weeks (p = 0.0005) by the switch to faricimab. Eight patients (44.4%) achieved a recurrence interval of ≥12 weeks. A history of subtenon injection of triamcinolone acetonide (p = 0.0034) and the presence of disorganization of the retinal inner layers (p = 0.0326) were found to be significantly associated with a recurrence interval of <12 weeks. The mean BCVAs were 0.23 ± 0.28 logMAR and 0.19 ± 0.23 logMAR, and the mean CMTs were 473.8 ± 222.0 µm and 381.3 ± 219.4 µm at baseline and 4 months, respectively, but these changes were not statistically significant. None of the patients experienced serious adverse events. Conclusions: Faricimab may extend the treatment interval for patients with DME that is refractory to ranibizumab or aflibercept. DME previously treated with the subtenon injection of triamcinolone acetonide or associated with disorganization of the retinal inner layers may be less likely to be associated with a longer recurrence interval after switching to faricimab.
Pooled safety analysis of the fixed-dose combination of indacaterol and glycopyrronium (QVA149), its monocomponents, and tiotropium versus placebo in COPD patients. [2020]To further assess the safety profile of the fixed-dose combination of indacaterol and glycopyrronium (QVA149) and its monocomponents; we investigated the impact of individual patient-level factors and time by integrating the patient-level safety data from the QVA149 clinical programme with relevant information from the independent indacaterol and glycopyrronium safety databases.
A 6-month comparison between formoterol and salmeterol in patients with reversible obstructive airways disease. [2019]The aim of this randomized, open, parallel group study was to compare the clinical efficacy of formoterol dry powder capsule 12 micrograms b.i.d. and salmeterol dry powder 50 micrograms b.i.d. in the treatment of patients with reversible obstructive airways disease. The 6-month treatment was preceded by a 2 week run-in period. Morning pre-dose peak expiratory flow (PEF) during the last 7 days of treatment was the primary variable. Throughout the study, patients recorded morning and evening pre-dose PEF, use of rescue medication, respiratory symptoms and adverse events. Clinic visits were scheduled at monthly intervals. Of the 482 patients randomized (equal numbers in the two treatment groups), 428 completed the study. Four hundred and twenty-five patients were included in the efficacy analysis for the primary variable. For mean morning pre-dose PEF during the last 7 days of treatment, the 95% confidence interval (CI) for the treatment contrast formoterol minus salmeterol was included entirely in the pre-defined range of equivalence (CI limits = -8.69, +9.841 min-1). This was also the case for the morning PEF during the last week before each clinic visit. For mean evening pre-dose PEF, the estimated treatment contrasts showed a trend towards superiority of formoterol over salmeterol, which became statistically significant at 2, 3 and 4 months (P
The impact of dual bronchodilation on cardiovascular serious adverse events and mortality in COPD: a quantitative synthesis. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">Long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are burdened by the potential risk of inducing cardiovascular serious adverse events (SAEs) in COPD patients. Since the risk of combining a LABA with a LAMA could be greater, we have carried out a quantitative synthesis to investigate the cardiovascular safety profile of LABA/LAMA fixed-dose combinations (FDCs).
Pharmacokinetics of Co-Suspension Delivery Technology Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate (BGF MDI) and Budesonide/Formoterol Fumarate Dihydrate (BFF MDI) Fixed-Dose Combinations Compared With an Active Control: A Phase 1, Randomized, Single-Dose, Crossover Study in Healthy Adults. [2020]This randomized, phase 1, single-dose, crossover study (NCT02189304) compared the 12-hour pharmacokinetic (PK) and safety profiles of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) 320/14.4/10 μg and budesonide/formoterol fumarate dihydrate (BFF) MDI 320/10 μg (both formulated using innovative co-suspension delivery technology) to an active comparator (budesonide/formoterol fumarate dihydrate dry powder inhaler [BUD/FORM DPI] 320/9-μg delivered dose) in healthy adults. The potential for PK interaction between glycopyrronium and budesonide/formoterol within BGF MDI was assessed. Of 72 subjects randomized, 59 completed treatment. Systemic budesonide exposure (primary objective) based on area under the plasma drug concentration-time curve 0-12 hours (AUC0-12 ; % coefficient of variation) was 1598.38 (49.7), 1657.09 (50.4), and 1276.75 (70.4) pg·h/mL for BGF MDI, BFF MDI, and BUD/FORM DPI, respectively; and formoterol exposure (AUC0-12 [% coefficient of variation]) was 39.16 (45.9), 39.53 (40.5), and 23.24 (59.2) pg·h/mL, respectively. BGF MDI and BFF MDI were bioequivalent for budesonide and formoterol. All treatments were well tolerated. While systemic exposure to budesonide and formoterol was higher for BGF MDI and BFF MDI than for BUD/FORM DPI, there were no appreciable differences in the incidence of pharmacologically predictable adverse events. This, coupled with the absence of PK interactions, suggests the BGF MDI safety profile will be comparable to BUD/FORM DPI.
Quantitative analysis of efficacy and safety of LABA/LAMA fixed-dose combinations in the treatment of stable COPD. [2022]This study aimed to quantitatively compare the efficacy and safety of long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combinations (FDCs) for the treatment of stable chronic obstructive pulmonary disease (COPD), especially in terms of their loss of efficacy in lung function.
[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.