Study of Danicopan for Patients with Geographic Atrophy Due to 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 an eye disease that can lead to vision loss in older adults. The study is testing a new treatment called Danicopan, also known by its code name ALXN 2040. Danicopan is taken as a film-coated tablet and is being evaluated for its effectiveness and safety in treating GA.

The purpose of this study is to find the right dose of Danicopan that can help patients with GA. Participants in the study will receive either Danicopan or a placebo, which looks like the real medication but does not contain the active substance. The study will last for a period of time, during which participants will take the medication and have regular check-ups to monitor their condition and any changes in their vision.

Throughout the study, researchers will assess how Danicopan affects the size of the GA lesions in the eye, as well as other aspects of eye health and vision. The study will also track any side effects or adverse events that participants may experience. This research aims to provide valuable information about the potential benefits and risks of using Danicopan for treating GA in patients with AMD.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, eye condition, and visual acuity using specific charts.

The total area of the geographic atrophy (GA) lesion in the eye is measured to ensure it meets the study criteria.

2 medication administration

Participants receive either danicopan (ALXN2040) or a placebo. The medication is provided in the form of a film-coated tablet for oral use.

The dosage and frequency of administration are determined by the study protocol, focusing on evaluating the effects of the medication over time.

3 regular monitoring

Participants undergo regular monitoring to assess changes in the GA lesion area and other eye health indicators.

These assessments occur at specified intervals, including baseline, week 52, and week 104, using various eye examination techniques.

4 safety and efficacy evaluation

The study evaluates the safety and efficacy of danicopan by monitoring for any adverse events or changes in eye health.

Participants’ plasma concentration of the medication is measured to understand how the body processes it.

5 completion of study

The study is expected to conclude by August 2025, with final assessments conducted to evaluate the long-term effects of the treatment.

Participants’ experiences and outcomes contribute to understanding the potential benefits and risks of danicopan for treating GA secondary to age-related macular degeneration.

Who Can Join the Study?

Must be 60 years or older, whether male or female.
Must have Geographic Atrophy (GA), which is a condition affecting the eye, caused by Age-related Macular Degeneration (AMD), in at least one eye.
The eye being studied must have a specific range of Visual Acuity (VA), which is a measure of how well you can see, between 20/20 and 20/320, using a special chart for eye tests.
The total area of the GA lesion, which is the damaged part of the eye, must be between 0.5 to 17.76 square millimeters per eye. If there are multiple damaged areas, at least one must be 0.5 square millimeters or larger.
The entire GA lesion must be more than 1 micrometer away from the center of the fovea, which is the part of the eye responsible for sharp vision.

Who Cannot Join the Study?

Patients who have any other eye diseases that could affect the study results.
Patients who have had eye surgery within the last three months.
Patients who are currently using other treatments for their eye condition that might interfere with the study.
Patients with a history of severe allergic reactions to medications.
Patients who have participated in another clinical trial within the last 30 days.
Patients with any serious health conditions that could make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Centre Hospitalier Intercommunal Creteil	Creteil	France
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
ASST Fatebenefratelli Sacco	Milan	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Clinica De Oftalmologia De Cordoba S.L.	Cordoba	Spain
Institut Catala De Retina S.L.	Barcelona	Spain
Oftex s.r.o.	Pardubice	Czechia
Centre Monticelli Paradis D Ophtalmologie	Marseille	France
Augenzentrum Am St Franziskus-Hospital Muenster	Munster	Germany
Diakonie Klinikum Dietrich Bonhoeffer GmbH	Neubrandenburg	Germany
Fondation A De Rothschild	Paris	France
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
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
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Philipps-Universitaet Marburg	Marburg	Germany
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Hospital General Universitario De Valencia	Valencia	Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Fakultna Nemocnica S Poliklinikou Zilina	Zilina	Slovakia
Centre Hospitalier Universitaire De Nice	Nice	France
Pole Vision Val D’Ouest	Ecully	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Budapest Retina Associates	Budapest	Hungary
Aqmp Ceqdluwm snnkqx	Prague	Czechia
Lqhfhgae Algemcod Agr Cfyinp Shm	Riga	Latvia
Ucdrhqvvpdw ncmmsvmrt &duibnz Nmkpowghd sqrlrzp Mhxdphbe an s	Bratislava	Slovakia
Uyrjpyuvvarbvsekvuvri Dedjjenigsu Anl	Duesseldorf	Germany
Ucudqqjuuzidrdelxgifi Mylksgox Akw	Munster	Germany
Ityrdpype Dj Mxrchsdekbgf Ozqryp Dzd Skdh	Barcelona	Spain
Hthqlfwt Vtwk dlhlybvr	Barcelona	Spain
Hdgahkqu Ugmgxndarcraaj Suzhwmzuvk &hedtoj Hydcaru dj Hjdlimgknai	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	28.07.2022
France	Not recruiting	28.07.2022
Germany	Not recruiting	28.07.2022
Hungary	Not recruiting	28.07.2022
Italy	Not recruiting	28.07.2022
Latvia	Not recruiting	28.07.2022
Slovakia	Not recruiting	28.07.2022
Spain	Not recruiting	28.07.2022

Trial locations

Investigated drugs:

Danicopan

Danicopan (ALXN2040) is a medication being studied for its potential to treat geographic atrophy, a condition that affects the eyes and is related to age-related macular degeneration. The trial aims to find the right dose of danicopan and to understand how safe and effective it is for patients with this eye condition.

Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) – Geographic atrophy is an advanced form of age-related macular degeneration, a common eye condition among older adults. It involves the progressive degeneration of the macula, the central part of the retina responsible for sharp vision. Over time, this leads to the formation of atrophic lesions, or areas where retinal cells have died, resulting in a gradual loss of central vision. The condition typically affects both eyes, although not always at the same rate. As the disease progresses, individuals may experience difficulties with tasks that require detailed vision, such as reading or recognizing faces. The progression of geographic atrophy can vary, with some people experiencing a slow decline in vision, while others may notice more rapid changes.

Trial ID:

2023-508571-37-00

Protocol code:

ALXN2040-GA-201

NCT ID:

NCT05019521

Trial Phase:

Therapeutic exploratory (Phase II)

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