RecruitingPHASE3INTERVENTIONAL

Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).

This study, called TIGER, is for people with a serious eye condition called submacular haemorrhage (SMH). This is when wet age-related macular degeneration (AMD) causes bleeding under the macula, the part of your eye that gives you sharp central vision. SMH can lead to severe vision loss. Currently, the main treatment for wet AMD and SMH is eye injections with 'anti-VEGF' drugs. This study wants to find out if adding a type of eye surgery, called a vitrectomy, along with the anti-VEGF injections, can lead to better vision compared to just having the injections alone. The aim is to improve care for people with this challenging condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

King's College Hospital NHS Trust

Enrolment target

210

Start

16 Apr 2021

Estimated completion

01 Dec 2028

Eye Diseases Macular Degeneration, Wet Sub-Macular Hemorrhage

What is this study about?

When you look at something, the central part of your vision, which you use for reading and recognising faces, comes from a special area at the back of your eye called the macula. Some people develop a condition called wet age-related macular degeneration (AMD), where tiny, abnormal blood vessels grow in the macula and leak fluid, making your vision blurry. In some cases, this can lead to a more serious problem called a submacular haemorrhage (SMH), which is a bleed right under the macula. This can cause very significant and lasting vision loss.

The usual treatment for wet AMD is a type of medicine called 'anti-VEGF' drugs, given through injections into the eye. These drugs help reduce the leakage and can improve eyesight. While anti-VEGF injections are also used for SMH, there isn't a specific licensed treatment for the bleeding itself, and doctors aren't entirely sure what the best approach is to get the most vision back when SMH occurs. This study aims to fill that gap.

This study will compare two ways of treating SMH. One group of people will receive the standard anti-VEGF injections. The other group will receive the same anti-VEGF injections, but also have eye surgery. The surgery involves removing some of the jelly from the eye, injecting a special medicine to help break down the blood clot under the macula, and then putting in a small gas bubble to help it heal. By comparing these two approaches, the researchers hope to learn whether adding surgery offers a real advantage and can improve vision better than injections alone for people with submacular haemorrhage.

Key takeaways

This study compares two treatments for bleeding under the macula (submacular haemorrhage) caused by wet AMD.
One treatment is standard eye injections; the other combines injections with a type of eye surgery.
The goal is to see if surgery can lead to better vision for this specific eye problem.
Participants will be randomly assigned to one of the two treatment groups.
The study lasts for 12 months with regular eye check-ups.
It aims to improve future care for people with this challenging eye condition.

Who may be eligible?

This study is looking for men and women aged 50 and over. To join, you must have a specific type of bleeding under your macula (submacular haemorrhage) caused by wet AMD. This bleeding needs to be in the very centre of your vision and be a certain size and thickness.

Your vision also needs to be within a specific range, from being able to count fingers up to what's considered good reading vision. This helps the researchers study how much improvement is possible.

You cannot join if you have certain serious allergies or if you've had a stroke, mini-stroke, or heart attack recently (within the last six months). You also cannot be taking part in another medical study or be pregnant, breastfeeding, or planning to become pregnant. Men with partners who could become pregnant also need to use contraception during the study.

Quick self-check

Are you 50 years old or older?
Do you have bleeding under your macula (submacular haemorrhage) due to wet AMD?
Is this bleeding in the very centre of your vision?
Is your eyesight currently within a specific range (not too good, not just total blindness)?
Have you had no stroke, mini-stroke, or heart attack in the last 6 months?
Are you not pregnant, breastfeeding, or planning to become pregnant during the study?

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

What does participation involve?

If you decide to take part in this study, the first step is to confirm the diagnosis of submacular haemorrhage and discuss the study fully. If you agree, you'll sign a consent form. Then, you'll have a thorough eye exam and vision tests to make sure you're suitable for the study.

Once accepted, you'll be randomly placed into one of two groups. One group will receive eye injections of anti-VEGF medicine, starting right away and then continuing every month for the first three months, and then every two months for the rest of the year. The other group will receive these same injections, but will also have eye surgery, which involves removing some jelly from the eye, giving a medicine to help clear the blood, and inserting a gas bubble. After the initial treatment, both groups will continue with regular follow-up visits and eye exams for a total of 12 months.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of improved vision for your submacular haemorrhage compared to current standard treatment, especially if the surgery proves helpful. However, like any medical procedure, there are potential risks, especially with surgery, which can include infection, bleeding, or other complications. The anti-VEGF injections also carry a small risk of side effects. The researchers will carefully monitor your health throughout the study. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (36)

University of Bonn
Bonn, Germany· Recruiting
University Medical Center Hamburg Eppendorf
Hamburg, Germany· Recruiting
Ludwig Maximilians-University München
München, Germany· Recruiting
Augenzentrum am St. Franziskus-Hospital Münster
Münster, Germany· Recruiting
Knappschaft Kliniken Saar GmbH, Sulzbach
Sulzbach, Germany· Recruiting
Ulm University Hospital
Ulm, Germany· Recruiting
University hospital of Würzburg
Würzburg, Germany· Recruiting
The Institute of Eye Surgery
Waterford, Ireland· Recruiting
Ophthalmology Clinic Jasne Błonia
Lodz, Poland· Recruiting
University Hospital Bern
Bern, Switzerland· Recruiting
Mid and South Essex NHS Foundation Trust
Chelmsford, United Kingdom· Recruiting
Kent & Canterbury Hospital (East Kent University)
Canterbury, United Kingdom· Recruiting

+24 more sites — see the official record for the full list.

Common questions

What is submacular haemorrhage?

It's a bleed that happens under the macula, the central part of your eye, often caused by wet age-related macular degeneration (AMD).

What are 'anti-VEGF' injections?

These are medicines injected into the eye that help stop leaky blood vessels from damaging your vision.

Will I definitely get the surgery if I join?

No, you will be randomly assigned to either receive just injections, or injections plus surgery. This is like flipping a coin.

How long will the study last for me?

If you take part, you will be followed for a total of 12 months.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your medical care.

How to find out more

Riti Desai, M.Sc.,M.Phil.

ritidesai@nhs.net 0044 2032991297 Official trial record

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