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

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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 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.

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

4 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

JNJ-81201887 (AAVCAGsCD59) – This medication is administered through an injection directly into the eye, known as an intravitreal injection. It is currently being studied in clinical trials for its potential to treat geographic atrophy, a condition related to age-related macular degeneration. The main goal of this treatment is to slow down the growth of lesions in the eye that occur with this condition. At the molecular level, it works by delivering a gene that produces a protein to help protect the eye cells from damage. This medication is classified as a gene therapy, which means it uses genetic material to treat or prevent disease.

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 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500746-16-00Protocol code81201887MDG2001Estimated enrolment285 patientsSponsorJanssen Cilag International

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