A Phase 4 interventional study of FARICIMAB 6 Mg in 0.05 mL INTRAVITREAL INJECTION, SOLUTION [VABYSMO] in Diabetic Macular Edema, sponsored by Vista Klinik. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Vista Klinik · Phase 4, Interventional, and Treatment
Among 13 studies testing faricimab in Macular Edema — 1 open to participants now, 3 under way, none of them phase 3. faricimab · Macular Edema.
Among the 13 studies testing faricimab in Macular Edema, this one is the 12th largest by planned enrollment, is one of 3 that started in 2022, is one of 4 in phase 4, and was the 11th registered.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
Browse Macular Edema studies →1 of the 13 studies testing faricimab in Macular Edema is open now. Recruiting first, the newest first:
Birmingham and Midland Eye Centre Sandwell and west Birmingham NHS trust
Ages 18+
faricimab: first FDA approval 2022 (VABYSMO), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 44 Macular Edema studies recruiting now, 31 (70%) set no upper age limit and 7 (16%) stop at 75 or younger; 1 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2022.
This study's planned enrollment of 30 is below the median of 56 across 584 interventional studies indexed under Macular Edema.
Median enrollment 229 across the 13 interventional studies. Of the 8 that completed or were terminated, 8 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 13 have an industry lead sponsor. The 6 most frequent:
Vista Klinik is the lead sponsor of 7 studies on the registry; none are open to participants now.
Vista Klinik has 1 study filed under Macular Edema — fewer than ten, so there is no comparison to draw.
2 of the studies testing faricimab in Macular Edema that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05610319McMaster UniversityTreat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial | 2026-12 |
| NCT05224102Genentech, Inc.A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema | 2027-01-26 |
Among the 13 studies testing faricimab in Macular Edema, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Title: Intravitreal faricimab in diabetic macular edema with limited response to aflibercept
Purpose: The purpose of this investigator initiated study is to identify the effects of intravitreal faricimab on recurrence-free treatment intervals and morphological features in diabetic macular edema (DME) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6 weeks intervals in a treat and extend regimen using aflibercept.
Objectives: The primary objective is to evaluate the proportion of patients with an increased maximum treatment interval with intravitreal faricimab (compared to previous 4-week interval under aflibercept) in an OCT guided treat and extend regimen at month 6 and 12. (for further outcome measures see section Objectives)
Title: Intravitreal faricimab in diabetic macular edema with limited response to aflibercept
Study purpose: The purpose of this investigator initiated study is to identify the effects of intravitreal faricimab on recurrence-free treatment intervals and morphological features in diabetic macular edema (DME) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6 weeks intervals in a treat and extend regimen using aflibercept.
Objectives: The primary objective is to evaluate the proportion of patients with an increased maximum treatment interval with intravitreal faricimab (compared to previous 4-week interval under aflibercept) in an OCT guided treat and extend regimen at month 6 and 12.
The secondary objectives are:
Population: This outpatient study population will consist of a representative group of male and female patients ≥ 18 years of age suffering from DME with a treatment interval of 4 weeks under aflibercept. All patients are pre-treated with intravitreal aflibercept for at least 6 months in a treat and extend regimen. For In-/Exclusion criteria see section Eligibility.
Sample size will be 30. This is a pilot study investigating faricimab in pretreated aflibercept high demanders with DME using a real-life like treat and extend schema. So far this population has not been investigated with faricimab. In the context of recent market approval in Switzerland a timely start of the study to generate prospective data in this population with the highest treatment burden is recommended.
Measurements and Procedures:
All consenting, enrolled patients will receive an intravitreal injection of faricimab 6 mg at baseline (week 0), at week 4, 8, 12 (=4x loading) and each of the following treat and extend visits. From visit 4 (week 12) onwards extension of treatment intervals is possible 2-week-stepwise, e.g. 4, 6, 8 weeks etc. Starting at week 12 at each visit the next treat and extend interval (and so the exact date of the next visit) will be defined depending on the following criteria:
Presence of any DME activity including:
→ new treatment interval = last treatment interval reduced by 2 weeks but minimum interval is 4 weeks, which means 4 weeks interval stays at 4 weeks, 6 weeks interval is reduced to 4 weeks etc
No signs of DME activity:
→ new treatment interval = last treatment interval plus 2 weeks
Efficacy assessment at 3 months is within loading phase; for efficacy assessments after 6, 9 and 12 months a treat and extend visit which takes place within 2 weeks before/after (meaning 24±2 weeks, 36±2 weeks and 48±2 weeks, respectively) can replace an extra assessment visit as far as the required examinations are performed.
Efficacy assessments:
Other assessments:
Study Product / Intervention:
This study will include the following drug:
Investigational therapy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vabysmo (Faricimab) 6 mg solution for intravitreal injection All consenting, enrolled patients will receive an intravitreal injection of faricimab 6 mg at baseline (week 0), at week 4, 8, 12 (=4x loading) and each of the following treat and extend visits up to month 12.
Drug: FARICIMAB 6 Mg in 0.05 mL INTRAVITREAL INJECTION, SOLUTION [VABYSMO]
Intravitreal injection of faricimab 6 mg at baseline (week 0), at week 4, 8, 12 (=4x loading) and each of the following treat and extend visits
Also known as: Vabysmo
maximum treatment interval with intravitreal faricimab at month 12.
maximum treatment interval with intravitreal faricimab at month 12.
Time frame: 12 months
BCVA
Best corrected visual acuity (BCVA) in letters and BCVA change (letters) from baseline (=switch to faricimab) to month 12.
Time frame: 12 months
injection number
Number of faricimab intravitreal treatments applied during the 12 months study period.
Time frame: 12 months
metamorphopsia index
AllEye index (metamorphopsia index) and change of AllEye index from baseline to month 12. The AllEye index (between 0 and 100) is a measure for quantification of metamorphopsia; high values implicate less metamorphosia.
Time frame: 12 months
CRT (Central retinal thickness)
Central retinal thickness (CRT, in µm) as measured in the central ETDRS subfield Spectral-Domain Optical coherence tomography (SD-OCT) and change in CRT from baseline to month 12.
Time frame: 12 months
VFQ-25 Quality of Life Score
National Eye Institute Visual Function Questionnaire (VFQ-25) total and subscores (maximum 100 points) and their change from baseline to month 12. Higher scores implicate better quality of life.
Time frame: 12 months
Contrast acuity (CA)
Contrast acuity (CA) measured as the area under the log CS function (AULCSF) and its change from baseline (=switch to faricimab) to month 12.
Time frame: 12 months
Contrast Sensitivity (CS) threshold
Cutoff Spatial frequency (Cutoff SF) in cycles per degree (cpd) and its change from baseline (=switch to faricimab) to month 12.
Time frame: 12 months
Intraretinal fluid
Presence of intraretinal fluid (yes/no) as a qualitative SD-OCT feature within the central ETDRS subfield at month 12.
Time frame: 12 months
Subretinal fluid
Presence of subretinal fluid (yes/no) as a qualitative SD-OCT feature within the central ETDRS subfield at month 12.
Time frame: 12 months
Hyperreflective foci
Presence of hyperreflective foci (yes/no) as a qualitative SD-OCT feature within the central ETDRS subfield at month 12.
Time frame: 12 months
FAZ (foveal avascular zone) area
FAZ (foveal avascular zone) area (mm2) as measured by OCTangiography (OCTA) and its change from baseline to month 12.
Time frame: 12 months
Vessel density (VD)
Vessel density (VD) as measured by OCTangiography (OCTA) and its change from baseline to month 12. VD is expressed as the ratio (%) of the total vessel area to the total area of analyzed region.
Time frame: 12 months
Adverse events
Rates of adverse events and serious adverse events at 12 months.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No — IPD share on special request
No publications or documents are linked to this record.
Start is estimated for Nov 2022; primary completion for Dec 2023, 13 months later.
Of 51 non-industry phase 4 interventional studies under Macular Edema, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 43. This study's planned 13 months is below that.
Counting every sponsor, half of 63 studies reached it within 26 months; a quarter within 15 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Faricimab
Vista Klinik