Eye bleeding study seeks best fix for macular degeneration patients
NCT ID NCT02557451
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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91 people
The number who actually took part.
- Started
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Apr 2016
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
Show the full entry requirements Hide 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
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AP-HP Hôpital Lariboisière
Paris, 75010, France
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CH de COLMAR
Colmar, 68000, France
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CH de MULHOUSE
Mulhouse, 68100, France
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CH de NEVERS
Nevers, 58000, France
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CHI de CRETEIL
Créteil, 94000, France
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CHR de METZ-THIONVILLE
Metz, 57085, France
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CHU de BESANCON
Besançon, 25030, France
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CHU de Bordeaux
Bordeaux, 33000, France
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CHU de DIJON
Dijon, 21079, France
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CHU de GRENOBLE
Grenoble, 38043, France
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CHU de NANCY
Vandœuvre-lès-Nancy, 54500, France
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CHU de REIMS
Reims, 51092, France
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CHU de TOULOUSE - Hôpital Purpan
Toulouse, 31300, France
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Clinique Mathilde
Rouen, 76100, France
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Fondation Ophtalmologique A. de Rothschild
Paris, 75019, France
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HCL - Hôpital de la Croix-Rousse
Lyon, 69004, France
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NHC de STRASBOURG
Strasbourg, 67091, France