Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New surgery trial aims to restore vision after macular bleeding

NCT ID NCT04663750

Disease control Sponsor: King's College Hospital NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether adding surgery (vitrectomy, clot-busting drug, and gas bubble) to standard anti-VEGF injections can improve vision more than injections alone for people with a macular bleed from wet AMD. About 210 participants across Europe will be randomly assigned to one of the two treatments. The main goal is to see if more patients gain at least 10 letters on an eye chart after 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aflibercept (anti-VEGF injection) and alteplase (tissue plasminogen activator)
What this could lead to
If successful, this could offer a new treatment option that improves vision recovery after a macular bleed in wet AMD.
What could go wrong
This is a surgical trial with added risks from the procedure, and it is still recruiting. The benefit over standard injections alone is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: General 1. Males or females aged at least 50 years Study eye 2. SMH, comprising sub-neuroretinal haemorrhage with or without sub-RPE haemorrhage, that occurs secondary to treatment naïve, or previously treated exudative AMD, including choroidal neovascularisation (CNV), idiopathic polypoidal choroidal vasculopathy (IPCV) and retinal angiomatous proliferation (RAP). 3. SMH involving the foveal centre that measures at least 1 disc diameter in greatest linear dimension. 4. Sub-neuroretinal haemorrhage at least 125 microns thick, measured at the foveal centre using spectral-domain optical coherence tomography (SD-OCT). 5. BCVA between counting fingers and an Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score of 70, inclusive. Exclusion Criteria: General 1. Serious allergy to fluorescein or indocyanine green (ICG). 2. Hypersensitivity to alteplase, gentamicin, arginine, phosphoric acid, polysorbate 80 or aflibercept. 3. Stroke, transient ischaemic attack or myocardial infarction within 6 months. 4. Participation in another interventional study within 12 weeks of enrolment or planned to occur during this study. 5. Women who are breast feeding, pregnant, or planning to become pregnant during the clinical trial. Any sexually active women of childbearing potential must agree continued abstinence from heterosexual intercourse or to use highly effective methods of birth control for the duration up to 12 weeks after administration of IMP or the last administration of aflibercept on the trial. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy. Females of childbearing potential are females who have experienced menarche and are not surgically sterilised (e.g. hysterectomy or bilateral salpingectomy) or post-menopausal (defined as at least 1 year since last regular menstrual period). Highly effective methods of birth control are those with a failure rate of \< 1% per year when employed consistently and correctly, eg. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation via oral, intravaginal, and transdermal routes; progestogen-only hormonal contraception associated with inhibition of ovulation via oral, injectable, implantable, intrauterine device (IUD), or intrauterine hormone-releasing system ( IUS); or vasectomised partner. 6. International Normalised Ratio (INR) greater than 3.5, unless it is anticipated that the INR can be brought below this level prior to vitrectomy, balancing the systemic risks with those of intraocular haemorrhage\*. 7. Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial. 8. Any other condition which, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol, such as dementia, mental illness, or serious systemic medical disease. Study eye 9. SMH that is known or estimated to have been present for longer than 15 days, as evidenced by history, pre-trial clinical documentation, or fundus appearance. 10. SMH due to eye disease other than exudative AMD. 11. Current active proliferative diabetic retinopathy. 12. Current intraocular inflammation. 13. Current ocular or periocular infection other than blepharitis. 14. Current or known former high myopia (\>6 dioptres). 15. Aphakia. 16. Other current or pre-existing ocular conditions that, in the opinion of the Investigator, will preclude any improvement in BCVA following resolution of SMH, such as severe central macular atrophy or fibrosis, dense amblyopia, macular hole involving the fovea, or very poor BCVA prior to presentation with SMH (counting fingers or worse). 17. Inadequate pupillary dilation or significant media opacities, which will prevent adequate clinical evaluation of the posterior segment or fundus imaging. 18. Intraocular surgery within 12 weeks of enrolment except for uncomplicated cataract surgery, which is permitted within 8 weeks of enrolment. * Applies only to participants receiving warfarin.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Eye diseases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

eye disorder wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eye diseases Macular degeneration, wet Sub-macular hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Augenzentrum am St. Franziskus-Hospital Münster

    RECRUITING

    Münster, Germany

  • Barts Health NHST trust - Whipps Cross University Hospital

    RECRUITING

    London, E11 1NR, United Kingdom

  • Belfast Health and Social Care Trust

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Bristol Eye Hospital

    RECRUITING

    Bristol, BS1 2LX, United Kingdom

  • Eye Clinic Ludwigshafen

    RECRUITING

    Ludwigshafen, Germany

  • Gartnavel General Hospital

    WITHDRAWN

    Glasgow, United Kingdom

  • Hospital Vall d'Hebron

    RECRUITING

    Barcelona, Spain

  • Hull Royal Infirmary

    RECRUITING

    Hull, Yorkshire, HU3 2JZ, United Kingdom

  • Imperial College Healthcare NHS Foundation Trust (The Western Eye Hospital)

    RECRUITING

    London, NW1 5QH, United Kingdom

  • James Cook University Hospital, (South Tees NHSFT)

    RECRUITING

    Middlesbrough, United Kingdom

  • Jules-Gonin Hospital

    RECRUITING

    Lausanne, Switzerland

  • Kent & Canterbury Hospital (East Kent University)

    RECRUITING

    Canterbury, Kent, CT1 3 NG, United Kingdom

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, London, SE5 9RS, United Kingdom

  • Knappschaft Kliniken Saar GmbH, Sulzbach

    RECRUITING

    Sulzbach, Germany

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, United Kingdom

  • Ludwig Maximilians-University München

    RECRUITING

    München, Germany

  • Maidstone and Tunbridge Wells NHS Trust

    RECRUITING

    Maidstone, ME16 9QQ, United Kingdom

  • Manchester Royal Eye Hospital

    RECRUITING

    Manchester, United Kingdom

  • Mid and South Essex NHS Foundation Trust

    RECRUITING

    Chelmsford, Essex, CM1 7ET, United Kingdom

  • Moorfields Eye Hospital

    RECRUITING

    London, EC1V 2PD, United Kingdom

  • New Cross Hosp, Royal Wolverhampton NHST

    RECRUITING

    Wolverhampton, United Kingdom

  • Nottingham University Hospitals

    RECRUITING

    Nottingham, United Kingdom

  • Ophthalmology Clinic Jasne Błonia

    RECRUITING

    Lodz, Poland

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • RadboudUMC

    RECRUITING

    Nijmegen, Netherlands

  • Rottherdam ophtalmic institute

    RECRUITING

    Rotterdam, Netherlands

  • Royal Devon and Exeter Hospital

    RECRUITING

    Exeter, United Kingdom

  • Royal Liverpool University Hospital

    RECRUITING

    Liverpool, L7 8 XP, United Kingdom

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Sunderland Eye Infimary

    RECRUITING

    Sunderland, Tyne and Wear, SR2 9HP, United Kingdom

  • The Institute of Eye Surgery

    RECRUITING

    Waterford, Ireland

  • The Princess Alexandra Eye Pavilion

    RECRUITING

    Edinburgh, Scotlan, EH3 9HA, United Kingdom

  • Torbay and South Devon NHS

    RECRUITING

    Torquay, TQ2 7AA, United Kingdom

  • Ulm University Hospital

    RECRUITING

    Ulm, Germany

  • University Hospital Bern

    RECRUITING

    Bern, Switzerland

  • University Hospital Southampton NHS foundation Trust

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • University Hospitals Plymouth NHST

    RECRUITING

    Plymouth, United Kingdom

  • University Hospitals Sussex NHS Trust

    WITHDRAWN

    Brighton, United Kingdom

  • University Medical Center Hamburg Eppendorf

    RECRUITING

    Hamburg, Germany

  • University hospital of Würzburg

    RECRUITING

    Würzburg, Germany

  • University of Bonn

    RECRUITING

    Bonn, Germany

  • Warsaw Ophthalmology Hospital

    RECRUITING

    Warsaw, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.