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Study on Long-term Safety of JNJ-81201887 for Patients with Geographic Atrophy Due to Age-related Macular Degeneration

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

8 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

JNJ-81201887 – This medication is administered through an intravitreal injection, which means it is injected directly into the eye. It is currently being studied in clinical trials for its long-term safety and tolerability in treating geographic atrophy, a condition related to age-related macular degeneration. The main therapeutic indication is to slow the progression of this eye disease. At the molecular level, it works by targeting specific pathways involved in the degeneration of retinal cells. It is classified pharmacologically as a treatment for eye disorders, specifically those affecting the retina.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500747-21-00Protocol code81201887MDG3002Estimated enrolment302 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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