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Enrolling by invitationPHASE2INTERVENTIONAL

ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study

This research, called ORACLE, is a follow-up study looking at the long-term safety of a treatment named GT005. It's for people who have Geographic Atrophy, a condition that can cause vision loss and is connected to Age-related Macular Degeneration (AMD). All participants in this study would have already received GT005 in one of our earlier studies. We want to understand how safe GT005 is over a longer period. There won't be any new GT005 given during this study. You would attend regular check-ups over about five years to help us gather important safety information.

At a glance

Status
Enrolling by invitation
Phase
PHASE2
Sponsor
Gyroscope Therapeutics Limited
Enrolment target
225
Start
12 Jul 2022
Estimated completion
02 Jun 2028
Age Related Macular Degeneration (AMD)

What is this study about?

This study, called ORACLE, is a long-term follow-up for people who previously took part in one of our research studies involving a treatment called GT005. The treatment was designed for Geographic Atrophy (GA), a type of advanced Age-related Macular Degeneration (AMD), which is an eye condition that can affect your central vision.

The main goal of ORACLE is to understand the long-term safety of GT005. When new treatments are developed, it's really important to keep checking on people who have received them, even years later, to make sure there are no unexpected side effects or issues that only show up over time. This helps us ensure treatments are as safe as possible.

In this study, you won't receive any new doses of GT005. Instead, we'll be inviting people who already had the treatment in earlier studies (named FOCUS, EXPLORE, or HORIZON) to come for regular check-ups. This allows doctors to monitor your health and eyesight over several years to gather crucial long-term safety data about GT005.

Key takeaways

  • This study checks the long-term safety of GT005 for Geographic Atrophy.
  • It's only for people who received GT005 in a previous research study.
  • No new treatment is given – it's a follow-up for monitoring.
  • Participation involves regular check-ups over about five years.
  • Your involvement helps gather important safety information for future treatments.

Who may be eligible?

This study is for adults generally aged 55 or older, and includes both men and women. The most important thing is that you must have previously participated in specific earlier studies involving the GT005 treatment.

Specifically, you must have received GT005 in one of these previous studies: GT005-01 (FOCUS), GT005-02 (EXPLORE), or GT005-03 (HORIZON). If you were in one of these studies, you might be eligible to join ORACLE.

Finally, you need to be willing and able to understand the study, sign a consent form, and attend the scheduled study visits and follow the procedures given throughout the study period.

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.

  1. Have I been treated with GT005 in an earlier study (FOCUS, EXPLORE, or HORIZON)?
  2. Am I willing to attend study visits for health and eye checks?
  3. Can I understand the study information and sign a consent form?
  4. Am I aged 55 or older?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the ORACLE study, you will have several study visits. There will be up to three visits in the first 96 weeks (about a year and nine months) and then up to five more visits after that. The total time you would be involved in the study is about five years from when you first received the GT005 treatment in the earlier study.

It's important to know that you will not receive any new medication or treatment (GT005) during this study. The purpose is purely to monitor your health and the long-term effects of the treatment you received previously. These visits will involve health checks and eye assessments to see how you are doing over time. You will be invited to join ORACLE once your participation in the previous GT005 study finishes, or if it ended early.

Potential risks and benefits

The main benefit of taking part in this study is contributing to important medical knowledge about the long-term safety of GT005 for Geographic Atrophy. This information could help future patients. As there's no new treatment given, the main 'risks' would be the time and travel involved in attending appointments, and any mild discomfort from standard eye examinations. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (32)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Retina Consultants San Diego - Poway
    Verified postcode
    Poway, United States
  • Southwest Retina Research Center
    Verified postcode
    Durango, United States
  • Vitreo Retinal Associates Pa - the Millennium Center Location
    Verified postcode
    Gainesville, United States
  • Rand Eye Institute, Inc. (Rei)
    Verified postcode
    Pompano Beach, United States
  • Retina Vitreous Associates of Florida
    Verified postcode
    St. Petersburg, United States
  • University Retina and Macula Associates, P.C. - Lemont Office
    Verified postcode
    Lemont, United States
  • Midwest Eye Institute Northside
    Verified postcode
    Indianapolis, United States
  • Wolfe Eye Clinic
    Verified postcode
    West Des Moines, United States
  • The Retina Care Center, Llc - Baltimore Location
    Verified postcode
    Baltimore, United States
  • Ophthalmic Consultants of Boston (OCB)
    Verified postcode
    Boston, United States
  • Pepose Vision Institute, P.C - Midwest Vision Research Foundation
    Verified postcode
    Chesterfield, United States
  • Sierra Eye Associates
    Verified postcode
    Reno, United States

Common questions

What is Geographic Atrophy (GA)?

Geographic Atrophy is an advanced form of 'dry' Age-related Macular Degeneration (AMD), an eye condition that can lead to central vision loss.

What is GT005?

GT005 is a treatment that was being tested in earlier studies for people with Geographic Atrophy. This ORACLE study is now checking its long-term safety.

Will I receive any treatment in this study?

No, this study is a follow-up only. You will not receive any GT005 or other experimental treatments during the ORACLE study.

How long will I be in the study?

The study will last for about five years from when you originally received GT005 in the previous study, involving a number of visits during that time.

Who can join this study?

This study is specifically for people who have previously received the GT005 treatment in one of the earlier FOCUS, EXPLORE, or HORIZON studies.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "ORACLE: A Long-term Follow-up Study to Evaluate the Safety o…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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