Table of contents
- Trial overview
- Who can participate
- What is being measured
- Study design and phase
- Trial status and size
- Key patient terms
Trial overview
The clinical trial listed for Gt005 is designed to study long-term safety in people with geographic atrophy secondary to age-related macular degeneration.[1] It focuses on participants who were already treated with Gt005 in earlier Gyroscope studies called GT005-01 (FOCUS), GT005-02 (EXPLORE), and GT005-03 (HORIZON).[1]
Who can participate
This study is for participants who have geographic atrophy caused by age-related macular degeneration and who have already received Gt005 in a prior study.[1] In simple terms, it is following people who were treated before, rather than starting with new participants.[1]
What is being measured
The main endpoint is the incidence and severity of ocular and systemic adverse events.[1] Incidence means how often these events happen, and severity means how serious they are.[1] Ocular adverse events are problems that affect the eye, while systemic adverse events affect the whole body.[1]
The study is also described as evaluating long-term safety for up to 5 years after treatment.[1] This means researchers want to learn how safe Gt005 remains over a long follow-up period.[1]
Study design and phase
This is an interventional study, which means researchers are giving a treatment and then observing what happens.[1] The trial is in Phase 1, which is an early stage of clinical testing that mainly looks at safety.[1] The intervention is listed as Drug: PPY988A (subretinal use), which is the study treatment name in the source data.[1]
Trial status and size
The trial status is Authorised.[1] The planned enrollment is 163 participants, meaning the study aims to include 163 people.[1]
Key patient terms
Geographic atrophy is a form of damage in the eye linked to age-related macular degeneration.[1] The macula is the part of the eye needed for clear central vision, so disease in this area can affect reading and seeing faces.[1] A clinical trial is a research study in people that helps doctors learn whether a treatment is safe and useful.[1]
