Study on Long-term Safety of JNJ-81201887 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, which is a type of vision loss that occurs as a result of Age-related Macular Degeneration (AMD). The study will use a treatment known as JNJ-81201887, which is a solution for injection. This treatment involves a special type of virus called an Adeno-associated virus that has been modified to carry a specific protein, soluble CD59, which may help in managing the condition. The purpose of the study is to assess the long-term safety and how well patients tolerate this treatment after it has been injected into the eye.

Participants in this study will have previously been involved in earlier studies where they received either the JNJ-81201887 treatment or a sham treatment, which is a procedure that mimics the treatment but does not contain the active substance. The study will monitor participants over time to observe any side effects or changes in their condition. This will include regular eye examinations and imaging tests to check the health of the retina, which is the part of the eye affected by Geographic Atrophy.

In addition to JNJ-81201887, the study will also involve the use of Prednisone, a medication that is commonly used to reduce inflammation. Participants may receive Prednisone in tablet form or a placebo that looks like the Prednisone tablets but does not contain the active ingredient. The study aims to gather comprehensive data on the safety of these treatments and their effects on the participants’ vision and overall health.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing previous participation in a parent clinical study involving JNJ-81201887 or a sham treatment.

Consent is required, which involves signing an informed consent form (ICF) to acknowledge understanding of the study’s purpose and procedures.

2 treatment administration

The study involves the administration of JNJ-81201887 through an intravitreal injection. This means the medication is injected directly into the eye.

The objective is to evaluate the long-term safety and tolerability of this treatment for geographic atrophy secondary to age-related macular degeneration.

3 medication regimen

Participants may receive Prednisone tablets, which are taken orally. The available dosages are 5 mg and 20 mg.

A placebo matching the Prednisone tablets may also be administered to some participants.

4 monitoring and assessments

Regular monitoring is conducted to identify any ocular and systemic treatment-emergent adverse events.

Clinical laboratory tests and safety assessments are performed periodically to ensure participant safety.

5 eye examinations

Participants undergo retinal imaging, including fundus autofluorescence (FAF), spectral-domain optical coherence tomography (SD-OCT), and color fundus photography (CFP).

Comprehensive eye examinations are conducted to monitor the condition of the eyes throughout the study.

6 study duration

The study is expected to continue until August 24, 2029.

Participants are involved in the study for the duration necessary to achieve the study’s objectives, with regular follow-ups and assessments.

Who Can Join the Study?

  • Participants must have been part of a previous study and received either the treatment called JNJ-81201887 or a fake treatment (sham).
  • Participants need to sign a document called an Informed Consent Form (ICF). This form shows that they understand the study’s purpose and what will happen during the study, and they agree to take part. In some cases, someone else, like a legal representative or a witness, can sign the form for them if allowed by local rules.
  • Both men and women can participate in the study.
  • The study includes people who might need extra protection or care, known as a vulnerable population.

Who Cannot Join the Study?

  • Patients who have any other eye diseases that could affect the study results.
  • Patients who have had any recent eye surgery or plan to have eye surgery during the study period.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have any serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
ASST Fatebenefratelli Sacco Milan Italy
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
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Clinica De Oftalmologia De Cordoba S.L. Cordoba Spain
Warszawski Szpital Okulistyczny Sp. z o.o. Warsaw Poland
Clinica Baviera S.A. Madrid Spain
Centro De Oftalmologia Barraquer S.A. Barcelona Spain
Oftalmologia Vistahermosa S.L. Burjassot Spain
Institut Catala De Retina S.L. Barcelona Spain
The Rotterdam Eye Hospital Rotterdam The Netherlands
Augenzentrum Am St Franziskus-Hospital Muenster Munster Germany
Rufino Silva & Joao Figueira Espaco Medico De Coimbra Lda. Coimbra Portugal
St Erik Eye Hospital Solna Sweden
Nozologen Kft. Pecs Hungary
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Stichting Radboud University Medical Center Nijmegen The Netherlands
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Ziekenhuis Oost Limburg Genk Belgium
Rigshospitalet Copenhagen Denmark
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Universitair Ziekenhuis Gent Gent Belgium
Universita’ Degli Studi Di Ferrara Ferrara Italy
Oftalmika Sp. z o.o. Bydgoszcz Poland
Universitätsklinikum Bonn AöR Bonn Germany
Afgf Cwmdvlek sxanww Prague Czechia
Ubpqghisjgwpnxbvpedih Mlzpszzr Acf Munster Germany
Crvkrr Hjqnzlqazs E Uqysoglaicfci Dd Coyszyg Eeqmhs Coimbra Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
24.02.2025
Czechia Czechia
Recruiting
24.02.2025
Denmark Denmark
Recruiting
24.02.2025
Germany Germany
Recruiting
24.02.2025
Hungary Hungary
Recruiting
24.02.2025
Italy Italy
Recruiting
24.02.2025
Poland Poland
Recruiting
24.02.2025
Portugal Portugal
Recruiting
24.02.2025
Spain Spain
Recruiting
24.02.2025
Sweden Sweden
Recruiting
24.02.2025
The Netherlands The Netherlands
Recruiting
24.02.2025

Trial locations

JNJ-81201887 is a medication being studied for its long-term safety and tolerability in patients with geographic atrophy, a condition related to age-related macular degeneration. This medication is administered through an injection into the eye, known as an intravitreal injection. The study aims to understand how well patients tolerate this treatment over an extended period.

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 patches. These patches cause a loss of central vision, making it difficult to read, recognize faces, or perform tasks requiring detailed vision. The disease progresses slowly over time, with the atrophic areas expanding and merging. Peripheral vision usually remains intact, allowing individuals to maintain some level of independence. Geographic Atrophy is often associated with age-related macular degeneration.

Trial ID:
2022-500747-21-00
Protocol code:
81201887MDG3002
Trial Phase:
Therapeutic exploratory (Phase II)

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