Testing new treatment for Geographic Atrophy treatment

Recruting new patients

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    What is this study about?

    This research study pertains to a condition affecting the eyes known as Geographic Atrophy (GA), stemming from the aging process (Age-related Macular Degeneration). The investigation aims to assess the potential efficacy of a new drug (JNJ-81201887), administered through intraocular injection, in improving the aforementioned condition. A comparative analysis will be conducted between individuals receiving the drug and those subjected to a placebo procedure (a simulated intervention lacking an actual drug). Specialized photographs will be taken to quantify any alterations in the condition over an 18-month period. Additionally, observations will be made regarding changes in distant visual acuity, reading ability, and the requirement for aids during these activities over time. Ultimately, the study will examine the impact of the eye condition on daily activities.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Genk , Belgium

      Gent , Belgium

      Leuven , Belgium

      Liege , Belgium

      Pardubice , Czechia

      Prague , Czechia

      Praha 10 , Czechia

      Aalborg , Denmark

      Glostrup , Denmark

      Roskilde , Denmark

      Berlin , Germany

      Bonn , Germany

      Gu00f6ttingen , Germany

      Hannover , Germany

      Leipzig , Germany

      Ludwigshafen am Rhein , Germany

      Muenster , Germany

      Muenster , Germany

      Tuebingen , Germany

      Pecs , Hungary

      Milano , Italy

      Roma , Italy

      Amsterdam , Netherlands

      Nijmegen , Netherlands

      Rotterdam , Netherlands

      Bydgoszcz , Poland

      Bydgoszcz , Poland

      Tarnow , Poland

      Warszawa , Poland

      Coimbra , Portugal

      Coimbra , Portugal

      Porto , Portugal

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Burjassot , Spain

      Cordoba , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Majadahonda , Spain

      Pamplona , Spain

      Sant Cugat del Valles , Spain

      Santiago de Compostela , Spain

      Sevilla , Spain

      Zaragoza , Spain

      Stockholm , Sweden

      London , United Kingdom

      London , United Kingdom

      Oxford , United Kingdom

      Southampton , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take in this clinical trial depend on the assigned treatment arm. Here are the steps for each of the three arms:

      1. Arm A: JNJ-81201887 Low Dose (Experimental)
        • Receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4.
        • Receive a 20-day oral prednisone course starting on Day 1.
        • Receive a single, long-acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
      2. Arm B: JNJ-81201887 High Dose (Experimental)
        • Receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4.
        • Receive a 20-day oral prednisone course starting on Day 1.
        • Receive a single, long-acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
      3. Arm C: Sham Procedure (Sham Comparator)
        • Receive a sham procedure that matches the single JNJ-81201887 injection on Day 4.
        • Receive a sham procedure that matches the long-acting periocular corticosteroid injection (triamcinolone) on Day 4.
        • Receive a 20-day placebo matching oral prednisone starting on Day 1.

      The medications administered to the experimental groups include the drug JNJ-81201887, oral prednisone, and triamcinolone, whereas the sham procedure group receives placebo and sham procedures to match the experimental interventions.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have the following disease:

      1. Non-subfoveal geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area that can be measured and measures 2.5 millimeter square (mm^2) to 17.5 mm^2 (1- and 7- disc areas respectively), as determined by the central reading center from screening images of fundus autofluorescence and spectral domain optical coherence tomography.

      If the GA is multifocal, at least one focal lesion must be greater than or equal to 1.25 mm^2 (0.5- disc area), as assessed by the central reading center.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      To join the study, you must meet the following conditions:

      1. Non-Subfoveal Geographic Atrophy (GA): You must have geographic atrophy secondary to age-related macular degeneration (AMD) that does not involve the center point of the fovea. This GA must have a measurable area between 2.5 millimeter square (mm^2) and 17.5 mm^2, which is equivalent to 1 to 7 disc areas, respectively. These measurements will be determined by the study’s central reading center (CRC) based on screening images.
      2. Multifocal GA: If the GA is multifocal, meaning it occurs in multiple spots, at least one focal lesion must be 1.25 mm^2 or larger, which is equivalent to at least a half-disc area.
      3. Full FAF Photography: The entire GA area must be capturable in a photo using fundus autofluorescence (FAF), which uses a 30-degree image centered on the fovea to measure changes in the back of the eye. These images help to assess the health and function of the retinal pigment epithelium.
      4. Fellow Eye Condition: Your fellow eye (the eye not being studied) must be intact and have a best corrected distance visual acuity (BCVA) of ‘counting fingers’ or better. BCVA is a measure of the best possible vision a person can achieve with corrective lenses and ‘counting fingers’ is a level of vision where a person can discern fingers being waved in front of them.
      5. Gender: Both men and women are eligible to participate in the study, with sex determined by reproductive anatomy and genetic complement.

      Please note that understanding these medical terms and conditions is crucial for determining eligibility for the clinical trial.

      What Reasons Could Exclude Me from the Study?

      Here is the list of conditions and their explanations that would exclude you from participating in the study:

      1. History of transpupillary thermotherapy: This is a type of laser treatment used on the eye.
      2. Photodynamic therapy: A two-step treatment that uses a light-sensitive drug and a particular type of light to destroy abnormal cells.
      3. External-beam radiation therapy in the region of study eye: A form of radiation therapy that is directed at the eye from an outside source.
      4. Prior thermal laser in the macular region: Any laser treatment that has been applied to the central area of the retina, regardless of the reason for treatment.
      5. History of retinal detachment (with or without repair): A serious condition where the retina pulls away from its normal position in the eye. The repair status does not affect the exclusion.
      6. Active, infectious conjunctivitis: Also known as pink eye, it is an infection or inflammation of the conjunctiva, the membrane that lines the eyelid and eye surface.
      7. Keratitis: Inflammation or infection of the cornea, the clear layer on the front of the eye.
      8. Scleritis: Inflammation of the sclera, the white outer wall of the eye.
      9. Endophthalmitis: Severe inflammation of the inside of the eye usually due to an infection.
      10. Diabetic retinopathy: Damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina), often caused by diabetes.
      11. Central serous chorioretinopathy: A condition that involves fluid buildup under the retina, disrupting your vision.

      You cannot take part in the study if any of the above apply to you.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. JNJ-81201887 (AAVCAGsCD59): This is the experimental drug administered as a single intravitreal injection. It will be administered in two different doses across different arms of the study. AAVCAGsCD59 is a gene therapy agent that is designed to deliver the CD59 gene to retina cells, which may provide a therapeutic benefit for geographic atrophy secondary to age-related macular degeneration.
      2. Prednisone: Prednisone is a corticosteroid used to reduce inflammation and suppress the immune system. In this study, it will be administered orally for 20 days starting on Day 1.
      3. Triamcinolone: Triamcinolone is another corticosteroid and it will be administered as a single, long acting periocular injection on Day 4 for prophylaxis of intraocular inflammation.

      In addition, there is a sham comparator in the study involving a sham procedure and placebo to match the interventions.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are as follows:

      1. JNJ-81201887 (also known as AAVCAGsCD59): This is an investigational drug that will be administered as an intravitreal injection. Regarding its known status in medical literature, because it is referred to as an investigational drug, it suggests that it may be a newer substance under investigation and might not yet be widely recognized or available outside of clinical trial settings.
      2. Prednisone: Prednisone is a well-known corticosteroid medication that will be administered as an oral capsule in the study. Prednisone is extensively used in medicine to treat a variety of conditions due to its potent anti-inflammatory and immunosuppressive effects.
      3. Triamcinolone: Another corticosteroid medication, triamcinolone will be administered as a periocular injection as per local practice. Triamcinolone is commonly used in medical settings, particularly for its anti-inflammatory effects.
      4. Placebo: A prednisone matching placebo will be administered as oral capsule to participants in the sham procedure arm. Placebo, by definition, does not contain an active substance intended to have a therapeutic effect, but is used in clinical trials to compare against the actual drug being studied.

      Study ID

      CT-EU-00068725

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago