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Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents and Age Related Macular Degeneration Complications (STAR)

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ClinicalTrials.gov Identifier: NCT02557451
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

AMD is a disease of the central retina, a zone that enables fine detail activities (reading, detail…). This central zone of the retina can be affected by a haemorrhagic complication when small abnormal vessels suddenly start to bleed inside the retina. Several therapeutic approaches are currently available even though they have never been truly compared. The study will be proposed to patients who need to be treated for haemorrhage of the macula. A certain number of factors will be evaluated to compare the 2 principal approaches currently used in France: surgery followed by injections of an anti-angiogenic OR intravitreal injections of gas followed by injections of anti-angiogenics. This is a multicentre, randomized controlled trial to compare these 2 therapeutic approaches.

These diametrically opposed approaches have very different consequences for patients and in terms of cost for society. The consequences for patients will be immediately measurable so as to determine the best therapeutic approach in terms of functional recovery and the impact of the disease on quality of life, while taking into account the risks inherent to these 2 treatments. The impact on quality of life of these 2 approaches as well as their consequences - an important factor in this disease, which is a cause of sensory handicap - will provide the ophthalmological community with essential information making it possible to validate one or the other of these methods for the management of these haematomas.


Condition or disease Intervention/treatment Phase
Subretinal Haematoma Linked to AMD Other: Surgery Other: Intravitreal injections of gas Procedure: injections of an antiangiogenic Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Subretinal Haematoma in AMD: Randomized Controlled Study of 2 Therapeutic Approaches in the Antiangiogenic Era
Actual Study Start Date : April 28, 2016
Estimated Primary Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: surgery + antiangiogenic
surgery (vitrectomy - air - TPA) with injections of an antiangiogenic
Other: Surgery
Procedure: injections of an antiangiogenic
Experimental: intravitreal injection of gas/TPA + antiangiogenic
intravitreal injection of gas - TPA with injections of an antiangiogenic
Other: Intravitreal injections of gas
Procedure: injections of an antiangiogenic



Primary Outcome Measures :
  1. Visual acuity measured on the ETDRS scale [ Time Frame: Change from inclusion at 3 months ]

Secondary Outcome Measures :
  1. Visual acuity measured on the ETDRS scale [ Time Frame: At 1 month and 6 months ]
  2. Area of the scotoma presented by the patient according to the Amsler grid [ Time Frame: At 1 month, 3 months and 6 months ]
  3. Quality of life using the VFQ-25 scale [ Time Frame: At 3 months and 6 months ]
  4. Number of injections of an antiangiogenic at the end of the 6 months of treatment [ Time Frame: At 6 months ]
  5. Number of patients with macular bleeding [ Time Frame: At 6 months ]
  6. Area of hypoautofluorescence using the autofluorescence technique [ Time Frame: At 3 and 6 months ]
  7. Complications rate [ Time Frame: At 6 months ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557451


Contacts
Contact: Alain BRON 3 80 29 51 73 ext +33 alain.bron@chu-dijon.fr

Locations
France
CHU de BESANCON Recruiting
Besancon, France, 25030
Contact: Maher SALEH    381667416 ext +33      
CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Marie-Noëlle DELYFER    557821216 ext +33      
CH de COLMAR Recruiting
Colmar, France, 68000
Contact: Laurent MEYER    626845294 ext +33      
CHI de CRETEIL Recruiting
Creteil, France, 94000
Contact: Agnès GLACET-BERNARD    145175221 ext +33      
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Alain BRON    3 80 29 51 73 ext +33    alain.bron@chu-dijon.fr   
CHU de GRENOBLE Recruiting
Grenoble, France, 38043
Contact: Christophe CHIQUET    476768457 ext +33      
HCL - Hôpital de la Croix-Rousse Recruiting
Lyon, France, 69004
Contact: Laurent KODJIKIAN    472071718 ext +33      
CHR de METZ-THIONVILLE Recruiting
Metz, France, 57085
Contact: Jean-Marc PERONE    387553428 ext +33      
CH de MULHOUSE Recruiting
Mulhouse, France, 68100
Contact: Patrick LENOBLE    389646205 ext +33      
CH de NEVERS Recruiting
Nevers, France, 58000
Contact: Akram GHRER    668150174 ext +33      
AP-HP Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Ramin TADAYONI    149956488 ext +33      
Fondation Ophtalmologique A. de Rothschild Recruiting
Paris, France, 75019
Contact: Yannick LE MER    148036671 ext +33      
CHU de REIMS Recruiting
Reims, France, 51092
Contact: Carl ARNDT    326787090 ext +33      
Clinique Mathilde Recruiting
Rouen, France, 76100
Contact: Joël UZZAN    609023911 ext +33      
NHC de STRASBOURG Recruiting
Strasbourg, France, 67091
Contact: David GAUCHER    369550437 ext +33      
CHU de TOULOUSE - Hôpital Purpan Recruiting
Toulouse, France, 31300
Contact: Vincent SOLER    561772233 ext +33      
CHU de NANCY Recruiting
Vandœuvre-lès-Nancy, France, 54500
Contact: Jean-Paul BERROD    383155101 ext +33      
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02557451     History of Changes
Other Study ID Numbers: BRON PHRC I 2013
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Macular Degeneration
Hematoma
Retinal Degeneration
Retinal Diseases
Eye Diseases
Hemorrhage
Pathologic Processes
Tissue Plasminogen Activator
Angiogenesis Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents