المتابعة طويلة الأمد للسلامة والفعالية لـ BIIB111 لعلاج التهاب الشبكية الصباغي المرتبط بالكروموسوم X و BIIB112 لعلاج التهاب الشبكية الصباغي المرتبط بالكروموسوم 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.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
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.
النقاط الرئيسية
- 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.
- يمكنك الانسحاب من الدراسة في أي وقت.
من قد يكون مؤهلاً؟
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.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك 18 سنة أو أكثر؟
- هل أنت ذكر؟
- 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?
ماذا يتضمن المشاركة؟
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.
المخاطر والفوائد المحتملة
المواقع (25)
- UCLA - Jules Stein Eye Instituteالرمز البريدي المؤكدلوس أنجلوس، الولايات المتحدة
- Vitreo Retinal Associates PA - The Millennium Centerالرمز البريدي المؤكدغينزفيل، الولايات المتحدة
- جامعة مياميالرمز البريدي المؤكدميامي، الولايات المتحدة
- Johns Hopkins Hospitalالرمز البريدي المؤكدبالتيمور، الولايات المتحدة
- MEEI Massachusets Eye and Ear Infirmaryالرمز البريدي المؤكدبوسطن، الولايات المتحدة
- مركز كولومبيا الطبي الجامعيالرمز البريدي المؤكدنيويورك، الولايات المتحدة
- Cincinnati Eye Institute - Blue Ashالرمز البريدي المؤكدسينسيناتي، الولايات المتحدة
- OHSU - Casey Eye Instituteالرمز البريدي المؤكدبورتلاند، الولايات المتحدة
- مؤسسة الشبكية في الجنوب الغربيالرمز البريدي المؤكددالاس، الولايات المتحدة
- University of Wisconsin School of Medicineالرمز البريدي المؤكدماديسون، الولايات المتحدة
- Instituto Genetica Ocularالرمز البريدي المؤكدساو باولو، البرازيل
- The Northern Alberta Clinical Trials and Research Centreالرمز البريدي المؤكدإدمونتون، كندا
أسئلة شائعة
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.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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