Not yet recruitingPHASE2INTERVENTIONAL

A Study in Adults With Geographic Atrophy

This research study is looking into a new medicine, STL303, for a serious eye condition called Geographic Atrophy (GA). GA is linked to Age-related Macular Degeneration (AMD) and causes a blurry or missing spot in the centre of your vision when cells in the back of your eye slowly stop working. The main goal is to find out if STL303 is safe to use and if it can help slow down the progression of GA. This study is for adults aged 60 and above. Participants will be randomly assigned to receive either the new medicine or a placebo (a dummy treatment) to fairly compare their effects, and neither they nor their doctors will know which they are receiving until the study ends. This is a common way to test new medicines.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Sitala Bio LTD

Enrolment target

300

Start

01 Jun 2026

Estimated completion

01 Aug 2029

Geographic Atrophy

What is this study about?

This study is vital because Geographic Atrophy (GA) is a leading cause of sight loss in older adults, and currently, there are very few treatments available. GA happens when light-sensing cells at the back of your eye, in an area called the macula, slowly die. This can lead to a growing blurry or blind spot right in the centre of your vision, making everyday tasks like reading or recognising faces very difficult. By testing new medicines like STL303, we hope to find ways to preserve vision and improve the quality of life for those affected by this condition.

The researchers are particularly interested in how STL303 works and whether it can protect these precious eye cells from further damage. They will be looking closely at how the medicine affects the size and growth of the GA patches in the eye. Understanding this better could lead to a future treatment that slows down, or even stops, this progressive vision loss.

This study will help us understand if STL303 is a safe option for patients and if it has a positive impact on their vision. Every step towards a new treatment brings hope to people living with GA and their families. This research is a crucial part of that journey, carefully and thoughtfully exploring potential solutions.

Key takeaways

This study is testing a new medicine (STL303) for Geographic Atrophy (GA).
It aims to find out if STL303 is safe and can slow down vision loss from GA.
Participants must be 60 years or older with diagnosed GA due to AMD.
You might receive the new medicine or a placebo; neither you nor your doctor will know which.
Participation involves regular eye exams, vision tests, and blood tests.
You can withdraw from the study at any time without affecting your future care.

Who may be eligible?

To join this study, you need to be at least 60 years old. You must have been diagnosed with a type of Age-related Macular Degeneration (AMD) called 'non-exudative' in both eyes. This means you have certain signs of AMD, often called drusen, which are small yellow deposits under the retina.

Critically, the 'study eye' – the eye that will be specifically monitored during the trial – must have Geographic Atrophy (GA) of a certain size and location. This GA area needs to be clearly visible on special eye scans. Your vision in this study eye also needs to be good enough, roughly meaning you can read most of the letters on an eye chart from a little distance. If both your eyes meet all the requirements, the eye with better vision will be chosen as the study eye. If vision is equal, it will be your right eye.

There are also some very specific technical requirements related to the GA patches in your eye that specialists will check using detailed scans. For example, the GA patch must be a certain distance from the very centre of your vision. These strict criteria help ensure that the study includes people who are most likely to benefit from the treatment and whose responses can be accurately measured.

Quick self-check

Are you 60 years old or older?
Have you been diagnosed with 'dry' Age-related Macular Degeneration (AMD) in both eyes?
Do you have Geographic Atrophy (GA) that falls within specific size requirements, as confirmed by an eye specialist?
Is your central vision in the eye being studied good enough (you can read 20/70 or better on an eye chart)?
Can you commit to regular study visits for eye check-ups and tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it will involve regular visits to the clinic over a period of time. During these visits, you will have several eye examinations, including vision tests and special scans of your eye, to monitor the Geographic Atrophy. Blood tests will also be taken to check your general health and how your body is reacting to the study medicine. You'll be given either the new medicine, STL303, or a placebo (a dummy drug that looks the same but contains no active medicine). Neither you nor your study doctor will know which one you are receiving – this is called 'double-masked' and is a standard way to ensure results are fair and unbiased. The exact number and frequency of visits, as well as the total length of your participation, will be explained in detail before you decide to take part. There will also be follow-up appointments after you stop receiving the study medicine to ensure your safety and monitor any long-term effects.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as contributing to medical knowledge and possibly, though not guaranteed, receiving a new treatment that could help your condition before it's widely available. However, there are also potential risks, including side effects from the study medicine, which will be thoroughly discussed with you. Some risks are also associated with the procedures, like eye examinations or blood tests. You will be closely monitored for any adverse effects, and your safety is the top priority. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time without explaining why, and it will not affect your future medical care.

Locations (60)

California Retina Consultants
Bakersfield, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, United States
Kaiser Permanente - Oakland
Oakland, United States
Retina Specialists of Colorado
Aurora, United States
Retina Group of New England, PC
Waterford, United States
Retina Vitreous Associates of Florida
St. Petersburg, United States
Florida Retina Institute
Wildwood, United States
University Retina and Macula Associates, P.C.
Lemont, United States
Associated Vitreoretinal and Uveitis Consultants
Carmel, United States
Cumberland Valley Retina Consultants,P.C.
Hagerstown, United States
Mid Atlantic Retina Specialists
Hagerstown, United States
Ophthalmic Consultants of Boston
Waltham, United States

+48 more sites — see the official record for the full list.

Common questions

What is Geographic Atrophy (GA)?

Geographic Atrophy is an advanced form of 'dry' Age-related Macular Degeneration (AMD) where light-sensing cells in the central part of your eye (the macula) gradually waste away, leading to blind spots in your central vision.

What is STL303?

STL303 is the identification code for a new investigational medicine being tested in this study. We are evaluating its safety and effectiveness for treating Geographic Atrophy.

What does 'randomised, double-masked' mean in a study?

It means you will be randomly assigned to receive either the new medicine or a placebo (dummy treatment), and neither you nor your study doctor will know which one you are getting. This helps make the study results as fair and unbiased as possible.

Will I definitely receive the new medicine?

No, because this is a 'randomised' study, you have an equal chance of receiving either the active study medicine (STL303) or a placebo (a treatment with no active drug) to allow for fair comparison.

What happens if my vision gets worse during the study?

Your vision and eye health will be regularly monitored throughout the study. If there are any significant changes or concerns, the study team will discuss appropriate medical care with you, and your safety is always the priority.

How to find out more

Clinical Operations Manager

studies@sitala.com +41815602193 Official trial record

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