Faricimab for Choroidal Neovascularization Secondary to Pathologic Myopia in Patients with Pathologic Myopia

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What is this study about?

This study is for choroidal neovascularization secondary to pathologic myopia, a serious eye problem in which abnormal blood vessels grow under the retina, the light-sensitive layer at the back of the eye. The trial is testing faricimab and comparing it with ranibizumab to see which treatment works better and how safe it is.

Both medicines are given as intravitreal injections, which means they are injected into the eye. In the study, treatment is given over time, and the eye is checked during the study visits to see how the condition changes and whether more than one injection is needed. The purpose of the study is to find out whether faricimab can help improve vision and control the eye disease as well as or better than ranibizumab.

1 study treatment begins

after joining the study, you receive an intravitreal injection, which means an injection into the eye.

you are assigned to receive either faricimab or ranibizumab.

faricimab is given as a 0.5 mg injection.

ranibizumab is given as a 6 mg injection.

the injection is given by the intravitreal route, meaning directly into the eye.

the study compares these two medicines to assess their effect and safety in your eye condition.

2 first 12 weeks after joining

your vision is measured and followed over time during the first 12 weeks.

the main vision result is the change in best corrected visual acuity (bcva), which means how well you can see with the best possible glasses or lenses.

this vision result is assessed as an average over weeks 4, 8, and 12.

the study also checks whether you gain at least 15 letters on the vision chart, whether you avoid losing at least 15 letters, and how many injections you receive by week 12.

the thickness of the central part of the retina is measured. this is called central subfield thickness (cst), which means the thickness of the middle area at the back of your eye.

the study also checks the total size of the cnv lesion, which means the abnormal new blood vessel area in the eye, and the amount of leakage from that area.

the presence or absence of macular leakage, meaning leaking in the central part of the retina, is also assessed at week 12.

3 follow-up through week 24

your vision and eye findings continue to be monitored through week 24.

the study tracks changes in bcva over time and checks whether your vision improves, stays stable, or worsens.

the study records how many injections you receive by week 24.

the study also checks whether you receive only one injection from the start of the study to week 24.

4 follow-up through week 48

your vision and eye findings continue to be monitored through week 48.

the study records the number of injections you receive by week 48.

the study checks whether you receive only one injection from the start of the study to week 48.

the size of the cnv lesion, the amount of leakage, and the presence or absence of macular leakage are also assessed at week 48.

5 safety monitoring during the study

during the study, the occurrence and severity of side effects in the eye are recorded.

side effects outside the eye are also recorded.

the study checks for ada, which means anti-drug antibodies. these are antibodies, or proteins made by the body, that may react to the study medicine.

the study also examines whether the presence of ada is linked to the study results for effectiveness or safety.

Who Can Join the Study?

The person must be in overall good health, based on a medical check that includes medical history, a physical examination, and laboratory tests.
The person must have no previous treatment for choroidal neovascularization caused by myopia in the study eye. Treatment-naïve means the eye has not been treated for this problem before.
The study eye must have an active form of myopic choroidal neovascularization (CNV), confirmed by an eye examination and review of the eye images by the study review team. Active means the abnormal blood vessels are currently present and causing activity of the disease.
Vision in the study eye must be between 78 and 24 letters on the eye chart test, which is about 20/32 to 20/320 vision. This is measured using a standard eye test called ETDRS, which is a detailed chart used to measure vision.
The study eye must have at least one type of lesion, meaning an area of abnormal tissue or blood vessels, with involvement of the central macular area. The allowed types are:
- Subfoveal: abnormal blood vessels are under the center of the retina, called the fovea, which is the area used for sharp central vision.
- Juxtafoveal: abnormal blood vessels are very close to the center of the fovea, within 200 micrometers (a very tiny distance, about one-fifth of a millimeter), and they affect the central macular area.
- Extrafoveal: abnormal blood vessels are more than 200 micrometers from the center of the fovea, and they affect the central macular area.
- Margin of the optic disc: abnormal blood vessels are near the edge of the optic disc, which is where the optic nerve enters the eye, and they affect the central macular area.
The clear parts of the eye must be clear enough, and the pupil must be able to widen enough, so that good-quality retinal images can be taken to confirm the diagnosis. Retinal images are pictures of the back of the eye.

Who Cannot Join the Study?

The eye problem must be caused by pathologic myopia. You cannot join if the choroidal neovascularization is caused by something else, such as neovascular age-related macular degeneration, ocular histoplasmosis, trauma (injury), angioid streaks, choroidal rupture, or uveitis (inflammation inside the eye).
You cannot join if you have any past macular problem that is not related to pathologic myopia and could affect vision or cause fluid in or under the retina. The macula is the part of the eye needed for sharp central vision.
You cannot join if screening shows central serous chorioretinopathy (fluid buildup under the retina) or myopic tractional maculopathy (damage to the macula from stretching caused by severe nearsightedness). You also cannot join if there is a retinal pigment epithelial tear involving the macula on Day 1. The retinal pigment epithelium is a thin layer that helps support the retina.
You cannot join if the non-study eye does not function well. This means the other eye has vision of 20/200 or worse in standard Snellen eye chart terms, or if the other eye is missing completely, meaning you have only one eye.
You cannot join if you have ever had faricimab injected into either eye before. IVT means an injection into the vitreous, the jelly-like fluid inside the eye.
You cannot join if you have ever had uveitis in either eye, either idiopathic (no known cause) or autoimmune-associated (caused by the body’s immune system).
You cannot join if there is active eye inflammation in either eye on Day 1, including inflammation in the front, middle, or back part of the eye. You also cannot join if there is a suspected or active eye infection or around-the-eye infection in either eye on Day 1.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Centre Hospitalier Intercommunal Creteil	Creteil	France
Universitaetsmedizin Goettingen	Goettingen	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Clinica De Oftalmologia De Cordoba S.L.	Cordoba	Spain
Knappschaft Kliniken Saar GmbH	Sulzbach	Germany
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.	Olsztyn	Poland
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia	Rome	Italy
Centre Monticelli Paradis D Ophtalmologie	Marseille	France
Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L.	Paris	France
Retina	Saint-Cyr-Sur-Loire	France
Oftalmologia Vistahermosa S.L.	Burjassot	Spain
Fondation A De Rothschild	Paris	France
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate	Chieti	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Quinze-Vingts National Ophthalmology Hospital	Paris	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Pole Vision Val D’Ouest	Ecully	France
Hopital Beaujon	Clichy	France
Lensclinic Sp. z o.o.	Rybnik	Poland
Reoptis Sp. z o.o.	Poznan	Poland
Pryzmat Sp. z o.o.	Gliwice	Poland
Lensclinic Sp. z o.o.	Rybnik	Poland
Ophtalmologie Maison Rouge S.C.M.	STRASBOURG, Alsace	France
University Hospital Consorziale Policlinico	Bari	Italy
Oftalmika Sp. z o.o.	Bydgoszcz	Poland
Gabinet Okulistyczny Prof Edward Wylegala	Katowice	Poland
Pghhatm Szp z onpu	Gliwice	Poland
Kqsnyzk Oeraqhnmhgwv Jnide Bxvrvf Soa z oizv	Lodz	Poland
Ckvnqgt Miphvmsi Dbnlvm 1d Sky z oenp	Cracow	Poland
Umjblraezk Htdvayij Cqafqqc	Cologne	Germany
Udvocuvcuggmlayfqfkzf Mwesycvj Ajs	Munster	Germany
Cje Cxwim Rwdracwhdbv	Lyon	France
Gejuxdq Oqctdqhahziw Jhslv Mvvuwkeacz	Lublin	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.03.2024
Germany	Not recruiting	01.03.2024
Italy	Not recruiting	01.03.2024
Poland	Not recruiting	01.03.2024
Spain	Not recruiting	01.03.2024

Trial locations

Investigated drugs:

Faricimab is the study treatment being tested in this trial. It is given as an injection into the eye. The trial is checking whether it can help treat abnormal new blood vessels in the back of the eye that are caused by pathologic myopia. Researchers want to see how well it works and how safe it is compared with the other treatment in the study.

Lucentis (ranibizumab) is the comparison treatment used in this trial. It is also given as an injection into the eye. It helps researchers compare how faricimab works and how safe it is against an approved eye treatment already used for this condition.

Choroidal Neovascularization Secondary to Pathologic Myopia – This condition is the growth of abnormal new blood vessels under the retina in people with pathologic myopia, which is severe near-sightedness with stretching and thinning of the eye. It usually develops because the back of the eye becomes damaged over time, allowing fragile vessels to form. These vessels can leak fluid or blood, causing swelling, distortion of vision, and gradual loss of central vision. The condition may worsen as the abnormal vessels enlarge or leak repeatedly, and scarring can develop in the affected area.

Trial ID:

2023-506707-25-00

Protocol code:

CR44829

Trial Phase:

Therapeutic confirmatory (Phase III)

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