Active not recruitingOBSERVATIONAL

Retinal Pigment Epithelium Safety Study for Patients in B4711001

This study is a follow-up to an earlier trial (B4711001) that tested a new treatment called PF-05206388 for age-related macular degeneration. If you took part in that first study and received the treatment, this new study aims to check your safety for an additional four years. The main goal is to carefully monitor your progress and make sure there are no unexpected problems. You will have regular check-ups to assess your health and the effects of the treatment over time. This gives researchers a more complete picture of the treatment's long-term safety, which is crucial for understanding its overall impact on patients with macular degeneration.

At a glance

Status

Active not recruiting

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Enrolment target

Start

16 Apr 2024

Estimated completion

30 Jun 2028

Age Related Macular Degeneration

What is this study about?

This study is about keeping an eye on people who have already taken part in a trial for a new treatment for age-related macular degeneration. Macular degeneration is an eye condition that can blur your central vision, making it harder to read or recognise faces.

The original study, called B4711001, investigated a treatment known as PF-05206388. This new study is not about testing a new drug or giving you more treatment. Instead, it's a 'safety follow-up' – a way to check in with participants from the first study for an extra four years. This helps researchers understand the long-term effects of the treatment and ensure everyone is doing well.

By carefully monitoring people for a longer period, doctors can learn more about how safe the treatment is over time. This kind of information is very important for knowing if a treatment is truly helpful and safe for people with macular degeneration in the long run.

Key takeaways

This is a safety follow-up for a previous study on macular degeneration.
It lasts for four years, with regular check-ups.
No new treatment is given; it's about monitoring your long-term health.
Only past participants of study B4711001 who received PF-05206388 can join.
Your contribution helps understand the treatment's long-term safety.

Who may be eligible?

This study is specifically for people who were already part of an earlier trial called B4711001. For this follow-up study, you must have received the treatment called PF-05206388 during that previous trial.

To join, you need to read and sign a consent form. This form explains everything about the study, and by signing it, you confirm you understand and agree to take part. You also need to be able and willing to come to all the scheduled appointments and follow the study's instructions.

There are no reasons that would stop you from taking part in this follow-up study, as long as you meet the conditions mentioned above. Participants can be aged 60 or older, and the study is open to both men and women.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Did I take part in the previous study B4711001?
Did I receive the PF-05206388 treatment in that study?
Am I aged 60 or older?
Am I able to attend regular appointments for the next four years?
Am I willing to sign a consent form after understanding the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this follow-up study, you will have regular visits to the clinic over a period of four years. These visits are mainly to assess your safety and how you are doing after receiving the treatment in the earlier study. This might include regular eye checks, general health assessments, and answering questions about your well-being. You won't be given any new medication as part of this follow-up study. The total duration of your involvement will be four years from the time you join this specific follow-up study.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of the long-term safety of the macular degeneration treatment you received previously. This knowledge can help future patients. As this is a pure safety follow-up, there are no direct medication benefits, but also no new risks from a study drug. The risks are typically limited to the inconvenience of clinic visits and standard medical tests. You are free to withdraw from the study at any time without explaining why, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
Verified postcode
London, United Kingdom

Common questions

What is the purpose of this study?

This study aims to check on the long-term safety of a treatment for macular degeneration that you received in a previous study (B4711001).

Will I receive any new treatment in this study?

No, this study is a follow-up to check your safety over time. You will not receive any new medication or treatment as part of this study.

How long will I need to be involved in this study?

If you join, you will be followed for a further four years with regular safety checks.

Who can take part in this study?

Only people who previously participated in study B4711001 and received the PF-05206388 treatment are eligible for this follow-up.

What happens if I no longer want to participate?

You are free to leave the study at any point, and it will not affect your routine medical care.