Active not recruitingOBSERVATIONAL

Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study

The i-GAIN study is an observational study for people with Geographic Atrophy (GA), a severe form of dry Age-related Macular Degeneration (AMD). This study aims to understand how GA progresses and identify specific markers from your blood that might help predict how the condition changes over time. Researchers will follow participants for up to 24 months, observing how their eye condition develops. They will also look at genetic factors and levels of certain proteins in the blood to see how these might be linked to changes in the macula, the part of your eye responsible for sharp, central vision. This research does not involve new treatments but is purely for observation.

At a glance

Status

Active not recruiting

Sponsor

Complement Therapeutics

Enrolment target

250

Start

07 Feb 2023

Estimated completion

31 Jul 2027

What is this study about?

This study, called 'i-GAIN', is all about understanding a specific eye condition called Geographic Atrophy (GA), which is a serious form of 'dry' Age-related Macular Degeneration (AMD). If you have GA, it means that parts of your macula – the central area of your retina which helps you see fine details – are wearing away, leading to blurry or missing central vision.

The main goal of this study is to simply observe and learn. Researchers want to see how GA naturally progresses over time without giving any new treatments. They are also very interested in finding 'biomarkers'. Think of biomarkers as clues in your body, like certain proteins in your blood, that might tell us more about how your GA is developing. By looking at these clues, alongside your genetic information and eye scans, they hope to get a clearer picture of this complex condition.

The information gathered from this study is incredibly important. It helps doctors and scientists understand GA better, which could eventually lead to new ways to diagnose, monitor, or even treat the condition in the future. For now, it's about building knowledge to improve care for people with GA.

Key takeaways

This study helps us understand Geographic Atrophy (GA) better.
It's an 'observational' study; you won't receive new treatments.
You will have regular eye checks and blood tests for up to 2 years.
The study focuses on people aged 65 and over with GA in both eyes.
The information learned could lead to better future care for GA patients.

Who may be eligible?

To join this study, you would need to be 65 years old or older and have a confirmed diagnosis of Geographic Atrophy (GA) in both eyes due to dry Age-related Macular Degeneration (AMD). The affected area in at least one of your eyes needs to be within a specific size range, which doctors will measure with special scans.

You wouldn't be able to join if you have 'wet' AMD in either eye, or if you've had certain eye treatments or conditions like severe short-sightedness (high myopia), or other eye problems that might make it hard to get clear pictures of your macula. Also, if you have certain other conditions like uveitis (inflammation inside the eye) or diabetic retinopathy, you wouldn't be able to take part.

It's important that you're able and willing to give your written consent to participate. 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.

Are you 65 years old or older?
Have you been diagnosed with Geographic Atrophy (GA) in both eyes due to dry AMD?
Do you NOT have 'wet' AMD in either eye?
Are you willing to have regular eye check-ups and blood tests for up to 2 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new medications or treatments. It's purely an 'observational' study. This means researchers will regularly check your eyes and take blood samples over a period of up to 24 months (two years).

During your visits, you can expect to have detailed eye examinations and special scans of your macula. Blood samples will be taken to look for specific proteins and genetic information. These visits will allow the research team to track any changes in your eye condition over time and see how they might relate to findings from your blood tests. The study will arrange all specific appointments and procedures.

Potential risks and benefits

Participating in this study might not directly benefit you with new treatments, but the information gained will be very valuable for understanding Geographic Atrophy (GA) and could help future patients. Taking part will involve regular eye exams and blood tests, which carry small, usual risks like minor discomfort from blood draws or temporary bright light from eye scans. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (22)

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

Global Research Management
Verified postcode
Glendale, United States
Northern California Retina Vitreous Associates
Verified postcode
Mountain View, United States
Midwest Eye Institute
Verified postcode
Carmel, United States
Mid Atlantic Retina Specialists
Verified postcode
Hagerstown, United States
Sierra Eye Associates
Verified postcode
Reno, United States
Verum Research LLC
Verified postcode
Eugene, United States
Mid Atlantic Retina
Verified postcode
Philadelphia, United States
Retina Research Institute of Texas
Verified postcode
Abilene, United States
Texas Retina Associates
Verified postcode
Plano, United States
San Antonio Eye Center
Verified postcode
San Antonio, United States
Belfast City Hospital
Verified postcode
Belfast, United Kingdom
Bradford Royal Infirmary
Verified postcode
Bradford, United Kingdom

Common questions

What is Geographic Atrophy (GA)?

GA is an advanced form of dry Age-related Macular Degeneration (AMD) where the cells in the central part of your vision (the macula) are slowly wearing away, causing blurry or missing patches in your sight.

Will I receive any new treatment in this study?

No, this is an 'observational' study, meaning researchers will only watch how your condition progresses over time. No new medications or treatments are given.

How long will I be involved in the study?

Your involvement in the study will last for up to 24 months, which is two years.

What will happen during the study visits?

You will have regular eye examinations, special scans of your macula, and blood tests to collect samples for analysis.

Are there any costs involved for me?

No, all study-related visits and procedures will be covered by the research study.