Study on the Effectiveness and Safety of ANX007 Injections for Patients with Geographic Atrophy from Age-Related Macular Degeneration

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What is this study about?

This clinical trial is focused on studying a condition called Geographic Atrophy (GA), which is a form of Age-Related Macular Degeneration (AMD). AMD is a common eye condition that affects the macula, the part of the eye responsible for clear central vision. The study is testing a treatment called ANX007, which is given as an injection directly into the eye, a method known as intravitreal injection.

The purpose of the study is to evaluate how effective and safe ANX007 is in improving visual function and clarity in patients with GA. Participants in the study will receive either the ANX007 injection or a placebo. The study will last for 24 months, during which participants will have monthly visits to monitor their progress and any side effects. The main goal is to see if ANX007 can help maintain or improve vision over time.

Throughout the study, researchers will closely observe any changes in vision and any potential side effects. The study will also track the overall safety of the treatment to ensure it is well-tolerated by participants. This research aims to provide valuable insights into the potential benefits of ANX007 for people living with GA due to AMD.

1 initial visit

The study begins with an initial visit where eligibility is confirmed. This includes a diagnosis of geographic atrophy related to age-related macular degeneration.

The study eye is selected based on specific criteria, including the size and characteristics of the geographic atrophy lesion.

2 baseline assessment

A baseline assessment is conducted to measure best corrected visual acuity (BCVA) using the ETDRS chart. This establishes a reference point for future comparisons.

3 treatment administration

The treatment involves intravitreal injections of ANX007. This is an injection directly into the eye.

The injections are administered monthly over a period of 24 months.

4 monthly follow-up visits

Monthly follow-up visits are required to monitor the patient’s condition and response to the treatment.

During these visits, assessments of visual function and visual acuity are conducted.

5 primary evaluation

The primary evaluation occurs between Month 12 and Month 18. This involves assessing the proportion of patients experiencing a significant loss in visual acuity.

6 secondary evaluation

Secondary evaluations focus on the incidence and severity of any adverse events related to the treatment. These evaluations occur through Month 12 and Month 24.

7 study completion

The study concludes after 24 months of treatment and monitoring. Final assessments are conducted to evaluate the overall efficacy and safety of the treatment.

Who Can Join the Study?

The patient must have a condition called Geographic Atrophy (GA) due to Age-Related Macular Degeneration (AMD).
If the patient has been receiving treatment for GA in the other eye with an approved drug for at least 3 months, they can continue this treatment. If the treatment has been for less than 3 months, they should not join the study. If the other eye has not been treated, it should not need treatment for at least the first year of the study, according to the doctor’s opinion.
The patient must be at least 50 years old when they sign the consent form.
The patient must be able and willing to participate in a study that lasts 24 months, with monthly visits.
The patient must have a diagnosis of GA of the macula due to AMD, confirmed by a doctor and an independent reading center.
The GA lesion must have specific characteristics, such as a well-defined area between 2.5 mm² and 17.5 mm², and must show a pattern called hyper autofluorescence in a specific zone. The entire lesion must be visible in an image centered on the macula and not connected to another condition called peripapillary atrophy.
The patient must have a certain level of vision, measured by a test called BCVA, which should be between 45 to 83 letters on a specific chart. If the vision test results differ by 10 or more letters between two tests, the patient will not be eligible.
A female patient can join if she is not pregnant or breastfeeding and meets certain conditions, such as being unable to have children or using a highly effective birth control method. She must also have a negative pregnancy test before starting the study.
The patient must be able to give signed consent, agreeing to follow the study’s requirements and restrictions.

Who Cannot Join the Study?

Patients with any other eye disease that could affect vision, apart from the condition being studied.
Patients who have had eye surgery in the past three months.
Patients with a history of severe allergic reactions to medications.
Patients who are currently participating in another clinical trial.
Patients with uncontrolled high blood pressure.
Patients with a history of stroke or heart attack in the past six months.
Patients who are pregnant or breastfeeding.
Patients with any serious illness that could interfere with the study.
Patients who have received any treatment for the condition being studied in the past three months.
Patients with a history of drug or alcohol abuse in the past year.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Centre Hospitalier Intercommunal Creteil	Creteil	France
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
ASST Fatebenefratelli Sacco	Milan	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Warszawski Szpital Okulistyczny Sp. z o.o.	Warsaw	Poland
Diakonie Klinikum Dietrich Bonhoeffer GmbH	Neubrandenburg	Germany
Augenzentrum Am St Franziskus-Hospital Muenster	Munster	Germany
Osrodek Chirurgii Oka Prof.Zagorskiego Sp. z o.o.	Rzeszow	Poland
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.	Olsztyn	Poland
Nozologen Kft.	Pecs	Hungary
Centre Monticelli Paradis D Ophtalmologie	Marseille	France
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia	Rome	Italy
Multimedica S.p.A.	Milan	Italy
Clinica Baviera S.A.	Madrid	Spain
Oftalmologia Vistahermosa S.L.	Burjassot	Spain
Institut Catala De Retina S.L.	Barcelona	Spain
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
University Of Debrecen	Debrecen	Hungary
Bajcsy-Zsilinszky Korhaz Es Rendelointezet	Budapest	Hungary
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Quinze-Vingts National Ophthalmology Hospital	Paris	France
Semmelweis University	Budapest	Hungary
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Pole Vision Val D’Ouest	Ecully	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Ophtalmologie Maison Rouge S.C.M.	STRASBOURG, Alsace	France
Budapest Retina Associates	Budapest	Hungary
Oftalmika Sp. z o.o.	Bydgoszcz	Poland
Metavision Arruzafa S.L.	Cordoba	Spain
Arqz Cwkzgfem sckhfz	Prague	Czechia
Vcfxfj Ouefhlypikxyd Rgemyuzv Swum	Sant Cugat Del Valles	Spain
Cihicdknw Sjq z ompe	Tarnowskie Gory	Poland
Cqtcbv Hjlnuwrwshs Ucimgvhkzqchl Dk Dtkrl	Dijon	France
Sxw Eczboqfuk Hnkvmczu Tqygcjj	Tilburg	The Netherlands
Jimttyhe Kwxhrm Uapzgpdxgp	Linz	Austria
Htgraxav Vtii duhkftor	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	03.03.2025
Czechia	Not recruiting	03.03.2025
France	Not recruiting	03.03.2025
Germany	Not recruiting	03.03.2025
Hungary	Not recruiting	03.03.2025
Italy	Not recruiting	03.03.2025
Poland	Not recruiting	03.03.2025
Spain	Not recruiting	03.03.2025
The Netherlands	Not recruiting	03.03.2025

Trial locations

Investigated drugs:

ANX007

ANX007 is a medication being studied for its potential to help patients with geographic atrophy, a condition related to age-related macular degeneration. It is administered through an injection into the eye, known as an intravitreal injection. The goal of this medication is to improve visual function and visual acuity, which means it aims to help patients see better and maintain their vision.

Geographic Atrophy Secondary to Age-Related Macular Degeneration – This condition is a progressive eye disease that affects the macula, the central part of the retina responsible for sharp vision. It is a form of age-related macular degeneration (AMD) characterized by the gradual loss of retinal cells, leading to areas of atrophy or thinning. As the disease progresses, these atrophic areas expand, causing a decline in central vision. Patients may experience difficulty with tasks that require detailed vision, such as reading or recognizing faces. The progression of geographic atrophy can vary, with some individuals experiencing a slow decline in vision over several years.

Trial ID:

2024-515022-88-00

Protocol code:

ANX007-GA-02

NCT ID:

NCT06510816

Trial Phase:

Therapeutic confirmatory (Phase III)

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