Seguimiento a Largo Plazo de la Seguridad y Eficacia de BIIB111 para el Tratamiento de la Coroideremia y BIIB112 para el Tratamiento de la Retinosis Pigmentaria Ligada al Cromosoma X
This research study is checking the long-term safety and how well two different treatments, called BIIB111 and BIIB112, work for rare genetic eye conditions. BIIB111 is for Choroideremia (CHM) and BIIB112 is for X-Linked Retinitis Pigmentosa (XLRP). Both conditions can lead to vision loss. This study is specifically for adult men who have already been treated with BIIB111 or BIIB112 in an earlier study. Researchers want to see how these treatments continue to affect vision and overall health over a longer period. Some participants with CHM who were in a previous study but didn't receive the treatment may also be included for comparison.
De un vistazo
¿De qué trata este estudio?
This research study is about two rare eye conditions: Choroideremia (CHM) and X-Linked Retinitis Pigmentosa (XLRP). Both of these conditions are genetic, meaning they run in families, and can cause progressive vision loss. Scientists are continuing to study potential treatments for these conditions, called BIIB111 for CHM and BIIB112 for XLRP.
This particular study is a follow-up, which means it’s looking at what happens to people over a longer period of time after they’ve already received one of these treatments. The main goal is to understand how safe these treatments are in the long run and how well they continue to help with vision. This is important because the effects of treatments for long-term conditions need to be carefully monitored.
The study involves people who have already taken part in an earlier study where they received BIIB111 or BIIB112. They will be compared with a small group of people with CHM who were part of an earlier study but didn't receive the treatment. This comparison helps researchers understand the true long-term effects of the treatments. The information gathered from this study will help us learn more about how to best manage and treat these serious eye conditions in the future.
Puntos clave
- This is a follow-up study for men previously treated for Choroideremia (CHM) or X-Linked Retinitis Pigmentosa (XLRP).
- It aims to track the long-term safety and effectiveness of treatments BIIB111 and BIIB112.
- Participants must be 18 years or older and have received the study treatment in a prior trial.
- The study involves ongoing eye checks and general health assessments.
- Information gathered will help improve future treatments for these rare eye conditions.
- Puede retirarse del estudio en cualquier momento.
¿Quién puede ser elegible?
This study is looking for adult men who are 18 years old or older. If you have **Choroideremia (CHM)**, you can join if you've already been part of another study where you received the BIIB111 treatment and that study has now ended. There will also be a small group of men with CHM joining who were in a previous study but did not receive the treatment.
If you have **X-Linked Retinitis Pigmentosa (XLRP)**, you can join if you've already received the BIIB112 treatment in a previous study and that study has now ended.
You should also be in good general health. The main reason someone might not be able to join is if the study doctor or sponsor believes it wouldn't be good for your health or well-being to take part. There might be other specific rules not listed here, so it’s always best to discuss with the study team.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Tienes 18 años o más?
- ¿Eres hombre?
- Have you been diagnosed with Choroideremia (CHM) or X-Linked Retinitis Pigmentosa (XLRP)?
- If you have CHM, did you previously receive BIIB111 in an earlier study?
- If you have XLRP, did you previously receive BIIB112 in an earlier study?
¿En qué consiste la participación?
If you decide to take part in this study, you would be invited for regular check-ups at a clinic. These visits will typically involve eye tests to measure your vision and monitor the health of your eyes. They will also include general health checks and blood tests to make sure the treatment is safe for you over time. You will continue to receive the BIIB111 or BIIB112 treatment as planned. The total length of your participation would depend on the study's design, but it is focused on long-term follow-up; you would be informed about the expected duration. The study team will explain everything in detail, including how often you'd need to visit and what each visit would involve.
Riesgos y beneficios potenciales
Locations (25)
- UCLA - Jules Stein Eye InstituteCódigo postal verificadoLos Angeles, United States
- Vitreo Retinal Associates PA - The Millennium CenterCódigo postal verificadoGainesville, Estados Unidos
- University of MiamiCódigo postal verificadoMiami, United States
- Johns Hopkins HospitalCódigo postal verificadoBaltimore, Estados Unidos
- MEEI Massachusets Eye and Ear InfirmaryCódigo postal verificadoBoston, Estados Unidos
- Columbia University Medical CenterCódigo postal verificadoNueva York, Estados Unidos
- Cincinnati Eye Institute - Blue AshCódigo postal verificadoCincinnati, Estados Unidos
- OHSU - Casey Eye InstituteCódigo postal verificadoPortland, Estados Unidos
- Retina Foundation of the SouthwestCódigo postal verificadoDallas, United States
- University of Wisconsin School of MedicineCódigo postal verificadoMadison, United States
- Instituto Genetica OcularCódigo postal verificadoSão Paulo, Brasil
- The Northern Alberta Clinical Trials and Research CentreCódigo postal verificadoEdmonton, Canadá
Preguntas comunes
What is Choroideremia (CHM)?
CHM is a rare, inherited eye disease that causes progressive vision loss, primarily in men, leading to blindness.
What is X-Linked Retinitis Pigmentosa (XLRP)?
XLRP is a genetic eye condition that also primarily affects men, causing the light-sensing cells in the retina to break down over time, leading to vision loss.
What does 'sub-retinal injection' mean?
This is a way of delivering medicine by injecting it directly into the space just under the retina, the light-sensitive tissue at the back of your eye.
Why are only men eligible for this study?
CHM and XLRP are 'X-linked' conditions, meaning they are primarily passed down and affect males, which is why this study focuses on male participants.
What does 'long-term safety and efficacy' mean?
It means the study is checking how safe the treatments are and how well they work over a longer period, not just for a few months.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.