Study on JNJ-81201887 for Treating Geographic Atrophy in Age-related Macular Degeneration Patients

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What is this study about?

This clinical trial is focused on studying a condition called Geographic Atrophy, 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 JNJ-81201887, also known as AAVCAGsCD59. This treatment is delivered as a solution for injection directly into the eye, a method known as intravitreal use. The purpose of the study is to see if this treatment can slow down the growth of the affected areas in the eye compared to a sham procedure, which is a procedure that mimics the treatment but does not contain the active medication.

Participants in the study will receive either the JNJ-81201887 treatment or a sham procedure. The study will monitor changes in the size of the affected areas in the eye over time. This will help researchers understand if the treatment is effective in slowing down the progression of Geographic Atrophy. The study will take place over a period of time, and participants will have regular check-ups to assess their eye health and the effects of the treatment.

In addition to the main treatment, some participants may receive other medications such as Prednisone, which is a type of steroid that can help reduce inflammation. Another medication that might be used is Kenacort-A, which contains Triamcinolone Acetonide, another type of steroid. These medications are given in tablet form or as a suspension for injection, depending on the specific needs of the study. The study aims to provide valuable information on the potential benefits of JNJ-81201887 for people with Geographic Atrophy due to Age-related Macular Degeneration.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study procedures and objectives will be explained to you. You will be asked to sign an informed consent form, indicating your understanding and willingness to participate in the study.

2 screening tests

You will undergo screening tests to confirm eligibility. This includes an eye examination to measure the area of geographic atrophy (GA) using imaging techniques such as fundus autofluorescence (FAF) and spectral-domain optical coherence tomography (SD-OCT).

If you are a woman of childbearing potential, a pregnancy test will be conducted to ensure you are not pregnant before receiving the study intervention.

3 randomization and treatment assignment

Once eligibility is confirmed, you will be randomly assigned to receive either the study treatment, JNJ-81201887, or a sham procedure. This process is double-masked, meaning neither you nor the study staff will know which treatment you are receiving.

4 treatment administration

If assigned to the treatment group, you will receive JNJ-81201887 as a solution for injection administered directly into the eye (intravitreal use).

You may also be prescribed Prednison acis tablets, which are taken orally. The dosage and frequency will be determined by the study protocol.

5 follow-up visits

You will have regular follow-up visits to monitor your condition and assess the effects of the treatment. These visits will include eye examinations and imaging tests to measure changes in the GA lesion area.

Additional medications, such as Kenacort-A 40, may be administered as needed during these visits.

6 end of study

The study is expected to conclude by July 2025. At the end of the study, you will have a final visit to assess your overall condition and discuss the results of your participation.

Who Can Join the Study?

Must be 60 years of age or older.
Have a condition called Geographic Atrophy (GA) that does not involve the center of the eye’s fovea, which is a small pit in the retina responsible for sharp vision. The affected area should be measurable and between 2.5 mm² to 17.5 mm² in size, as determined by specific eye imaging tests.
If a woman is able to have children, she must have a negative pregnancy test before starting the study.
Must sign a document called an Informed Consent Form (ICF), which shows that the participant understands the study’s purpose and procedures, agrees to take part, and can complete all necessary assessments. In some cases, this form can be signed by a witness or a legally authorized representative, depending on local rules.

Who Cannot Join the Study?

Individuals who do not have Geographic Atrophy, a condition affecting the eyes, cannot participate.
Participants must be within certain age ranges, typically adults and older adults.
Both males and females are eligible, but certain health conditions may exclude participation.
Individuals considered part of a vulnerable population, such as those with certain disabilities or health conditions, may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitaet Leipzig	Leipzig	Germany
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Katholieke Universiteit te Leuven	Leuven	Belgium
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
Hospital Universitario De Navarra	Pamplona	Spain
Hospitais da Universidade de Coimbra	Coimbra	Portugal

Other Sites

Site Name	City	Country
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Ziekenhuis Oost Limburg	Genk	Belgium
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Hospital Unviersitario Miguel Servet	Zaragoza	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Aalborg University Hospital	Aalborg	Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
Centro Medico Teknon-Grupo Quironsalud	Barcelona	Spain
ASST Fatebenefratelli Sacco	Milan	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Provincial De Conxo	Santiago De Compostela	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
St Erik Eye Hospital	Solna	Sweden
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
The Rotterdam Eye Hospital	Rotterdam	The Netherlands
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Nozologen Kft.	Pecs	Hungary
Centro De Oftalmologia Barraquer S.A.	Barcelona	Spain
Institut Catala De Retina S.L.	Barcelona	Spain
Clinica De Oftalmologia De Cordoba S.L.	Cordoba	Spain
Oftex s.r.o.	Pardubice	Czechia
Augenzentrum Am St Franziskus-Hospital Muenster	Munster	Germany
Warszawski Szpital Okulistyczny Sp. z o.o.	Warsaw	Poland
Oftalmologia Vistahermosa S.L.	Burjassot	Spain
Clinica Baviera S.A.	Madrid	Spain
Rufino Silva & Joao Figueira Espaco Medico De Coimbra Lda.	Coimbra	Portugal
Centrum Medyczne Uno-Med Sp. z o.o.	Tarnow	Poland
Zealand University Hospital	Koege	Denmark
Oftalmika Sp. z o.o.	Bydgoszcz	Poland
Sloibkunw Rwfqcpd Uzcsnyhcva Miqntlc Cisbjx	Nijmegen	The Netherlands
Otfjajmrmgz Sdz z obrz	Bydgoszcz	Poland
Cbpbsfso Somavmcz Iauryvjk	Barcelona	Spain
Apnf Crrupmwj shyjbh	Prague	Czechia
Ukumkdtbsvwsozpskvclo Mbgepdgt Akt	Munster	Germany
Ahcmsdmzb Umh	Amsterdam	The Netherlands
Hzcsazon Ugkfdscdvyvij Dfvzjffh	Donostia / San Sebastian	Spain
Rhpjhjxfvepenl	Glostrup	Denmark
Mruvsnb Ciclcz Hedgludvt Drgkaxn Fusrve	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.05.2023
Czechia	Not recruiting	01.05.2023
Denmark	Not recruiting	01.05.2023
Germany	Not recruiting	01.05.2023
Hungary	Not recruiting	01.05.2023
Italy	Not recruiting	01.05.2023
Poland	Not recruiting	01.05.2023
Portugal	Not recruiting	01.05.2023
Spain	Not recruiting	01.05.2023
Sweden	Not recruiting	01.05.2023
The Netherlands	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

JNJ-81201887 is a treatment being studied for its potential to help people with a condition called Geographic Atrophy, which is a part of Age-related Macular Degeneration. This condition affects the eyes and can lead to vision loss. The treatment is given through an injection directly into the eye. The goal of this treatment is to slow down the growth of the damaged areas in the eye, which could help preserve vision for a longer time. This study is comparing the effects of this treatment to a procedure that does not include the active medication, to see how well it works in slowing down the disease.

Geographic Atrophy – Geographic Atrophy is a progressive eye disease that affects the macula, the central part of the retina responsible for sharp vision. It is characterized by the gradual degeneration of retinal cells, leading to the formation of atrophic lesions. These lesions cause a loss of photoreceptors, which are crucial for capturing light and enabling vision. As the disease progresses, the affected areas of the retina expand, resulting in a gradual decline in central vision. Patients may experience difficulty in recognizing faces, reading, and performing tasks that require detailed vision. The progression of the disease is typically slow, with symptoms worsening over time.

Trial ID:

2022-500746-16-00

Protocol code:

81201887MDG2001

Trial Phase:

Therapeutic exploratory (Phase II)

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