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Eye bleeding study seeks best fix for macular degeneration patients

NCT ID NCT02557451

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 91 people with a type of bleeding in the eye caused by age-related macular degeneration (AMD). It compared two treatments: surgery followed by anti-VEGF injections, or a gas injection followed by anti-VEGF injections. The goal was to see which approach helps patients recover vision and quality of life better.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

91 people

The number who actually took part.

Started

Apr 2016

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 years and older

Sex

Anyone

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: Patients presenting subretinal haematoma linked to AMD * Occurring at least14 days before the start of therapy * With the presence of a component overlying the pigmentary epithelium (PE) on the OCT * And a diameter greater than two pupillary diameters on the retinal photographs Patients who have provided oral consent Patients with National Health Insurance cover Patients available for monthly follow-up Patient having an effective contraception for the women old enough to procreate during the treatment and during 6 months which follow his stop. Exclusion Criteria: * Subretinal haematoma linked to a cause other than AMD (myopia, angioid streaks…) * History of subretinal haematoma on the same side * Cloudy humour making it impossible to photograph the fundus of the eye or carry out angiography * Component of the haematoma exclusively underlying the pigmentry epithelium * Haemorrhage without lifting of the retina * Patients presenting an INR greater than 4, thus contra-indicating surgery * Patients requiring cataract surgery in the first 3 months of the study * Patients presenting a contra-indication relative to injection of the antiangiogenic (History of AVC bleeding or unknown origin in the last 6 months or MI in the 3 preceding months) * Pregnant or breast-feeding woman (the patients do not have to breast-feed during at least 6 months after the administration of the last dose of the antiangiogénique) * Contraindication in the use of ranibizumab: hypersensitivity in the active ingredient or in one of the excipients, eye infection or périoculaire active or suspected, inflammation intraoculaire active severe, treatments anti-VEGF systematic or eye concomitant, * Contraindication in the use of bevacizumab: hypersensitivity in the active substance or in one of the excipients, the hypersensitivity in the products of the ovarian cells of Chinese hamster (CHO) or in other antibodies human or humanized recombinants, heavy surgical operation dating less than 28 days, not totally healed surgical wound, history of lung bleeding or hémoptysie * Contraindication in the use of alteplase: hypersensitivity in the active substance, in the gentamicine (a residue of the present manufacturing process in the state of tracks), or in one of the excipients. As all the thrombolytic agents, contraindication in every case associated to a high hemorrhagic risk (current significant hemorrhagic disorder or during the last six months, hemorrhagic known diathesis, concomitant treatment by oral anticoagulants with effective dose, severe or potentially dangerous, obvious or recent bleeding, histories or suspicion of intra-cranial bleeding, suspicion of sub-arachnoid bleeding or history of sub-arachnoid bleeding bound to an aneurysm, histories of severe lesion of the central nervous system (for example néoplasie, aneurysm, surgical operation intracerebral or intrathecal), recent traumatic external cardiac massage (less than 10 days), delivery, recent draining of a vessel not accessible to the compression (for example draining of the subclavian or jugular vein),severe uncontrolled high blood pressure, bacterial endocarditis, pericarditis, acute pancreatitis, gastrointestinal ulcers documented during the last 3 months, esophageal varices, arterial aneurysm, arterial or venous deformations, neoplasia increasing the hemorrhagic risk, severe hepatic disease, including hepatic insufficiency, cirrhosis, portal hypertension (esophageal varicose veins) and evolutionary hepatitis, surgical operation or important traumas during the last 3 months. * Contraindication in the use of acetazolamide: hypersensitivity in the acetazolamide or in one of excipients, severe hepatic, renal or suprarenal inadequacies, intolerance in sulphonamide, histories of renal colic, allergy in the wheat (other than the coeliac disease).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • AP-HP Hôpital Lariboisière

    Paris, 75010, France

  • CH de COLMAR

    Colmar, 68000, France

  • CH de MULHOUSE

    Mulhouse, 68100, France

  • CH de NEVERS

    Nevers, 58000, France

  • CHI de CRETEIL

    Créteil, 94000, France

  • CHR de METZ-THIONVILLE

    Metz, 57085, France

  • CHU de BESANCON

    Besançon, 25030, France

  • CHU de Bordeaux

    Bordeaux, 33000, France

  • CHU de DIJON

    Dijon, 21079, France

  • CHU de GRENOBLE

    Grenoble, 38043, France

  • CHU de NANCY

    Vandœuvre-lès-Nancy, 54500, France

  • CHU de REIMS

    Reims, 51092, France

  • CHU de TOULOUSE - Hôpital Purpan

    Toulouse, 31300, France

  • Clinique Mathilde

    Rouen, 76100, France

  • Fondation Ophtalmologique A. de Rothschild

    Paris, 75019, France

  • HCL - Hôpital de la Croix-Rousse

    Lyon, 69004, France

  • NHC de STRASBOURG

    Strasbourg, 67091, France