A study investigating the effectiveness, safety and quality of life in participants with age related visual impairment (macular degeneration) who have switched to faricimab, under real world conditions in Germany

ISRCTN	ISRCTN27514808
DOI	https://doi.org/10.1186/ISRCTN27514808
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	ML44059
Sponsor	Roche Pharma (Roche Germany)
Funder	Roche Pharma AG (Roche Germany)

Submission date: 06/09/2023
Registration date: 07/09/2023
Last edited: 17/07/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Neovascular age-related macular degeneration (nAMD) is a disease that causes damage to the light-sensitive layer at the back of the eye (retina) leading to loss of sharp fine detailed vision required for daily activities such as reading, driving, and recognizing faces. A group of medicines called anti-vascular endothelial growth factors (aVEGF) have been a great success in treating patients with nAMD. However, in the long term, real-world results seem to be declining and may vary. Faricimab is a drug for administration into the eye via a fine needle (intravitreal injection) treatment used in patients with nAMD. Faricimab is approved by the United States Food and Drug Administration and the European Commission for the treatment of nAMD. The main aim of this study is to gather knowledge by collecting long-term data on previously treated participants with nAMD and to better understand the effectiveness, safety, and influence on the quality of life of faricimab in previously treated patients with nAMD under real-world conditions.

Who can participate?
Patients aged at least 50 years old with nAMD

What does the study involve?
Participants will take part in this study for approximately 24 months. Participants treated with faricimab will be observed in this 24-month period and the corresponding long-term data will be collected.

Study doctors will collect information regarding the participants’ age, gender, ethnicity, and relevant clinical parameters from interviews or medical examinations according to local practice. The details on faricimab therapy and reasons for changes, if applicable, will be recorded at each visit.

Additionally, the quality of life of the participants will also be assessed using a set of questionnaires called National Eye Institute Visual Function Questionnaire [NEI VFQ-25] and Short Form-36 Health Survey [SF-36] questionnaire. Participants are required to fill out these questionnaires at specified time points.

What are the possible benefits and risks of participating?
It is not intended that participants will receive any benefit from this study. The data collected might help in the better understanding of the limitations of the current therapies for nAMD, the reason for non-adherence, and the treatment patterns in a real-world setting.

There may be unknown or unforeseen risks, including privacy risks, associated with participating in this study.
Only the data available from routine clinical practice will be collected; thus, there could be some missing data.
The data to be captured for this study will be collected from the sites where diagnosis and treatment of disorders of the eye take place (ophthalmologic sites) and not from any other healthcare providers. Hence there may be an under-reporting of the data other than that related to eye and related disorders.

Where is the study run from?
Roche Pharma AG (Roche Germany)

When is the study starting and how long is it expected to run for?
November 2022 to June 2027

Who is funding the study?
Roche Pharma AG (Roche Germany)

Who is the main contact?
global.trial_information@roche.com

Contact information

Dr Clinical Trials
Public

Emil-Barell-Straße 1
Grenzach-Wyhlen
DE-79639
Germany

Phone	+41 616878333
Email	global.trial_information@roche.com

Study information

Primary study design	Observational
Study design	Single-arm prospective multicenter non-interventional study
Secondary study design	Case series
Study type	Participant information sheet
Scientific title	A non-interventional, multicenter study to investigate effectiveness, safety and quality of life in nAMD switch patients treated with faricimab under real world conditions in Germany
Study acronym	PASSENGER
Study objectives	The aim of the study is to evaluate the effectiveness of intravitreal injection treatment of faricimab on maintaining vision in previously treated neovascular age related macular degeneration (nAMD) participants treated for the first time with faricimab under real-world conditions.
Ethics approval(s)	Approved 10/01/2023, Westphalia-Lippe Ethics Commission (Ethik-Kommission Westfalen-Lippe) (Gartenstr. 210–214, Munster, 48147, Germany; +49 (0)251 929 2460; ethik-kommission@aekwl.de), ref: 2022-847-f-S
Health condition(s) or problem(s) studied	Neovascular age related macular degeneration (nAMD)
Intervention	Participants will be observed for effectiveness, safety, and quality of life once every 4 weeks during the loading dose phase (if applicable) and thereafter according to routine clinical practice for treatment (approximately once every 8 weeks to once every 16 weeks) for 24 months. Participants will also be required to fill out certain questionnaires such as the National Eye Institute Visual Function Questionnaire [NEI VFQ-25] and Short Form-36 Health Survey [SF-36] during the study. Optical coherence tomography (OCT) images of the participants that are collected within the scope of routine clinical practice during this study, will be additionally analysed by imaging experts in three different reading centers.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Faricimab
Primary outcome measure(s)	Mean change from baseline in visual acuity measured per local practice at Week 52
Key secondary outcome measure(s)	1. Percentage of participants with an extended treatment interval without losing >4 letters in best-corrected visual acuity (BCVA) compared to baseline measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 and Week 104 2. Percentage of participants with an extended treatment interval compared to baseline measured by ETDRS Letter Score at Week 52 and Week 104 3. Percentage of participants in different treatment intervals compared to baseline measured using data collected on the electronic case report form (eCRF) after 52 Weeks 4. Percentage of participants in different treatment intervals compared to baseline measured using data collected on the eCRF after 104 Weeks 5. Mean change from baseline in visual acuity assessed using ETDRS Letter Score at Week 104 6. Mean change from baseline in central subfield thickness (CST) measured by the reading center using OCT from baseline up to Week 104 7. Mean change from baseline in central point thickness (CPT), measured by the investigator using OCT from baseline up to Week 104 8. Percentage of participants with the absence of intraretinal fluid (IRF) within the ETDRS Grid measured by the investigator using OCT from baseline up to Week 104 9. Percentage of participants with the absence of subretinal fluid (SRF) within the ETDRS Grid measured by the investigator using OCT from baseline up to Week 104 10. Percentage of participants with absence of sub-retinal pigment epithelium fluid (Sub-RPE fluid) within the ETDRS grid measured by the investigator using OCT from baseline up to Week 104 11. Percentage of participants with absence of IRF and SRF within the ETDRS grid measured by the investigator using OCT from baseline up to Week 104 12. Percentage of participants with absence of IRF, SRF and Sub-RPE fluid within the ETDRS grid measured by the investigator using OCT from baseline up to Week 104 13. Percentage of participants with pigment epithelial detachment (PED) within the ETDRS grid measured by the investigator using OCT from baseline up to Week 104 14. Percentage of participants with no or with clinically insignificant fluid within the ETDRS grid measured using OCT from baseline up to Week 104 15. Regime of switch of therapy measured using data collected on the eCRFs from baseline up to Week 104 16. Number of injections after treatment initiation with faricimab measured using data collected on the eCRF from baseline up to Week 104 17. Number of faricimab injections measured using data collected on the eCRF at Weeks 52 and 104 18. Number of reasons for therapy switch to faricimab given by the participants measured using data collected on the eCRF from baseline up to Week 104 19. Percentage of participants with treatment adherence and non-adherence measured using data collected on the eCRF up to Week 52 20. Percentage of participants with treatment adherence and non-adherence measured using data collected on the eCRF up to Week 104 21. Number of reasons for treatment non-adherence given by participants measured using data collected on the eCRF up to Week 104 22. Number of reasons for therapy switch from faricimab measured using data collected on the eCRF from baseline up to Week 104 23. Number of reasons for discontinuation of faricimab measured using data collected on the eCRF from baseline up to Week 104 24. Mean change from baseline in NEI VFQ-25 measured using NEI VFQ-25 Questionnaire at Weeks 52 and 104 25. Mean change from baseline in SF-36 score measured using SF-36 Questionnaire at Weeks 52 and 104 26. Mean score of NEI VFQ-25 measured using NEI VFQ-25 Questionnaire at baseline, Weeks 52 and 104 27. Mean score of SF-36 measured using SF-36 Questionnaire at baseline, Weeks 52 and 104 28. Percentage of participants with serious adverse events (SAEs), non-serious AEs and AEs of special interest (AESIs) up to approximately 48 months
Completion date	30/06/2027

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	50 Years
Sex	All
Target sample size at registration	620
Key inclusion criteria	Current inclusion criteria as of 17/07/2024: 1. Signed informed consent 2. Diagnosis of nAMD 3. Is at least 50 years old 4. Previously treated with an (anti) vascular endothelial growth factor (aVEGF)-drug (at least 3 doses) but no longer than 36 months since the first aVEGF injection (study eye) with clinical features of diabetic retinopathy (e.g.: microaneuryms, hemorrhages, etc.) 5. The last injection of the previous aVEGF has to be longer than 4 weeks before the first faricimab injection 6. Active nAMD, defined as persistent IRF and/or SRF on OCT despite treatment with aVEGF therapy or participants who could benefit from treatment intervals beyond their current standard treatment 7. BCVA in the study eye between 30 and 80 letters of ETDRS at first faricimab treatment _____ Previous inclusion criteria: 1. Signed informed consent 2. Diagnosis of nAMD 3. Is at least 50 years old 4. Previously treated with an (anti) vascular endothelial growth factor (aVEGF)-drug (at least 3 doses) but no longer than 24 months since the first aVEGF injection (study eye) 5. The last injection of the previous aVEGF has to be longer than 4 weeks before the first faricimab injection 6. Active nAMD, defined as persistent IRF and/or SRF on OCT despite treatment with aVEGF therapy or participants who could benefit from treatment intervals beyond their current standard treatment 7. BCVA in the study eye between 30 and 80 letters of ETDRS at first faricimab treatment
Key exclusion criteria	1. Off-label use of faricimab 2. Previously treated with photodynamic therapy and retinal laser therapy (study eye) 3. Other retinal disease/intraocular condition (e.g., diabetic retinopathy, diabetic macular oedema, myopia >-6 diopter, angioid streaks, vision-reducing cataract) that, in the opinion of the investigator, could have an influence on the visual acuity (study eye) 4. Medical history of diabetes type 1 or 2 5. Participation in any other ophthalmological interventional and/or non-interventional study 6. Previously treated with faricimab (study eye); however, the first faricimab treatment may have occurred up to 12 weeks prior to enrollment 7. Pregnant and/or breastfeeding
Date of first enrolment	28/06/2023
Date of final enrolment	27/06/2025

Locations

Countries of recruitment

Germany

Study participating centres

Augenabteilung am St. Franziskus-Hospital

Munster
48145
Germany

Augenarztpraxis Dr.Mihaescu & Kollegen

Würzburg
97080
Germany

MVZ Augenzentrum am Berliner Ring

Würzburg
97080
Germany

Augentagesklinik am Spreebogen Berlin

Berlin
10559
Germany

AUGENZENTRUM auf der Insel,

Pfaffenhofen an der Ilm
85276
Germany

Südblick GmbH - Augenzentrum Prinz 25; Makula & Drye Eye Center

Augsburg
86150
Germany

Augenärzte Hamburg Dr. Kaupke MVZ GmbH

Hamburg
22587
Germany

Augenheilkunde Oberricklingen Hannover

30459
Germany

St. Elisabeth Krankenhaus Köln Hohenlind Köln

50935
Germany

Dietrich-Bonnhöffer-Klinikum Neubrandenburg

17036
Germany

Augenzentrum Frankfurt Prof. Koch und Dr. Deuchler

60549
Germany

Institut für Augenheilkunde Halle Halle

06114
Germany

Praxis Dr. Roxana Fulga Köln

50968
Germany

Augenklinik Petrisberg Trier

54296
Germany

Chiemsee Augen Tagesklinik Prien

83209
Germany

Augenzentrum Schildergasse Köln

50667
Germany

Augenklinik Stralsund Stralsund

18435
Germany

Augenklinik Dardenne Bonn

66113
Germany

Asklepios HH-Nord/Heidberg Hamburg

22417
Germany

Sankt Gertrauden-Krankenhaus Berlin

10713
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/07/2024: The following changes were made to the trial record:
1. The inclusion criteria were changed.
2. The study participating centres Augenheilkunde Oberricklingen Hannover, St. Elisabeth Krankenhaus Köln Hohenlind Köln, Dietrich-Bonnhöffer-Klinikum Neubrandenburg, Augenzentrum Frankfurt Prof. Koch und Dr. Deuchler, Institut für Augenheilkunde Halle Halle, Praxis Dr. Roxana Fulga Köln, Augenklinik Petrisberg Trier, Chiemsee Augen Tagesklinik Prien, Augenklinik Stralsund Stralsund, Augenklinik Dardenne Bonn, Asklepios HH-Nord/Heidberg Hamburg, Sankt Gertrauden-Krankenhaus Berlin were added.
04/12/2023: The following changes were made to the trial record:
1. The contact email and telephone number were changed.
2. The sponsor email and telephone number were changed.
3. The plain English summary was updated to reflect these changes.
07/09/2023: Studies existence confirmed by Westphalia-Lippe Ethics Commission (Ethik-Kommission Westfalen-Lippe) (Germany).