Long-term Extension Study for Participants with Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies

The primary objective of this study is to evaluate the long-term **safety** and tolerability of the intravitreal injection of JNJ-81201887 in participants with **Geographic Atrophy** secondary to Age-related Macular Degeneration, who have previously participated in parent clinical studies. This is clinically relevant as it aims to ensure the continued safety of the treatment over an extended period, which is crucial for chronic conditions like Geographic Atrophy where long-term management is necessary.

The clinical trial involves a total of **182 participants** who are being evaluated for the long-term safety and tolerability of an intravitreal injection of JNJ-81201887, following their participation in parent clinical studies. The study population includes both **male and female** subjects, with an age range that corresponds to categories 3 and 4, indicating a mature adult demographic. Participants were selected based on their prior enrollment and treatment in a parent study involving JNJ-81201887 or a sham procedure. The trial specifically targets individuals with **Geographic Atrophy**, a condition characterized by progressive and irreversible vision loss. The study population includes vulnerable groups, ensuring comprehensive safety assessments across diverse demographics. Lifestyle factors such as diet, physical activity, and habits are not specified in the available data.

The clinical trial is designed as a **randomized**, **double-blind**, and **controlled** study to evaluate the long-term safety and tolerability of an **intravitreal injection** of JNJ-81201887 in participants with **Geographic Atrophy** secondary to **Age-related Macular Degeneration**. The trial is a Phase 4 extension study, following participants who were previously enrolled in parent clinical studies. The trial is expected to commence recruitment on February 24, 2025, and conclude by August 24, 2029, with an estimated duration of participant involvement being approximately four years. Participants will be required to attend a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on prior enrollment and treatment in the parent study. Subsequent follow-up visits will be scheduled to monitor ocular and systemic treatment-emergent adverse events, conduct clinical laboratory and safety assessments, and perform retinal imaging and eye examinations. The end-of-study visit will mark the completion of the participant's involvement in the trial. Conditions that may lead to early termination from the study include the occurrence of significant adverse events or withdrawal of consent. The study will utilize a placebo to match Prednisone 20mg and 5mg, alongside the investigational product, to ensure the integrity of the double-blind design. Participants must sign an informed consent form, which may be signed by an impartial witness or legally designated representative, depending on national or local regulations. The primary endpoints focus on safety assessments, while no secondary endpoints are specified. The trial aims to provide comprehensive data on the long-term effects of the investigational product in the specified patient population.

The clinical trial involves the administration of several treatments, including both experimental and non-experimental medications. **Kenacort-A 40** is a suspension for injection containing **triamcinolone acetonide** as the active substance. It is manufactured by Bristol-Myers Squibb B.V. and is administered via ocular use. The dosage form is a suspension with a concentration of 40 mg/ml. The administration frequency and specific dosing schedule are not detailed in the provided data.

**JNJ-81201887** is an experimental treatment formulated as a solution for injection. It contains **adeno-associated virus serotype 2 encoding soluble CD59** as the active substance. This product is developed by Janssen-Cilag International N.V. and is administered intravitreally. The dosing unit is in milliliters, but specific dosing amounts and schedules are not provided. The treatment is part of an advanced therapy involving a viral vector with a serotype 2 capsid, designed for in vivo gene transfer.

**Prednison acis** is available in tablet form with two dosage strengths: 20 mg and 5 mg. The active substance is **prednisone**, and the product is manufactured by Acis Arzneimittel GmbH. The tablets are administered orally. The trial includes a placebo designed to match the appearance of the Prednison acis tablets, ensuring blinding in the study. The placebo does not contain any active substance and is used to compare the effects of the active treatment.

Participant compliance with the dosing regimen is monitored throughout the trial, although specific methods of compliance monitoring are not detailed in the provided data. The maximum treatment period for each medication is specified as one unit of time, but the exact duration is not defined. The trial aims to assess the long-term safety and tolerability of these treatments in participants with geographic atrophy secondary to age-related macular degeneration.

The efficacy of the clinical trial will be assessed through a series of primary endpoints focused on safety and tolerability. These endpoints include the evaluation of ocular and systemic treatment-emergent adverse events, clinical laboratory and safety assessments, as well as retinal imaging and eye examinations. The retinal imaging will utilize techniques such as Fundus Autofluorescence (FAF), Spectral-Domain Optical Coherence Tomography (SD-OCT), and Color Fundus Photography (CFP) to monitor changes in the retina. These assessments are designed to provide comprehensive data on the safety profile of the investigational product, **JNJ-81201887**, in participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).