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CompletedNCT02557451STARUpdated Feb 9, 2026

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

An interventional study of Surgery and Intravitreal injections of gas in Subretinal Haematoma Linked to AMD, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 17 sites in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
50 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Subretinal Haematoma Linked to AMD
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In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All

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

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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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • 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

Interventions

  • OtherSurgery
  • OtherIntravitreal injections of gas
  • Procedureinjections of an antiangiogenic
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What researchers measure

Primary outcomes

  1. Visual acuity measured on the ETDRS scale

    Time frame: Change from inclusion at 3 months

Secondary outcomes

  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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Study locations

17 sites
  • CHU de BESANCON
    Besançon, 25030, France
  • CHU de Bordeaux
    Bordeaux, 33000, France
  • CH de COLMAR
    Colmar, 68000, France
  • CHI de CRETEIL
    Créteil, 94000, France
  • CHU de DIJON
    Dijon, 21079, France
  • CHU de GRENOBLE
    Grenoble, 38043, France
  • HCL - Hôpital de la Croix-Rousse
    Lyon, 69004, France
  • CHR de METZ-THIONVILLE
    Metz, 57085, France
  • CH de MULHOUSE
    Mulhouse, 68100, France
  • CH de NEVERS
    Nevers, 58000, France
  • AP-HP Hôpital Lariboisière
    Paris, 75010, France
  • Fondation Ophtalmologique A. de Rothschild
    Paris, 75019, France
  • CHU de REIMS
    Reims, 51092, France
  • Clinique Mathilde
    Rouen, 76100, France
  • NHC de STRASBOURG
    Strasbourg, 67091, France
  • CHU de TOULOUSE - Hôpital Purpan
    Toulouse, 31300, France
  • CHU de NANCY
    Vandœuvre-lès-Nancy, 54500, France
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References and documents

Publications

  • Gabrielle PH, Delyfer MN, Glacet-Bernard A, Conart JB, Uzzan J, Kodjikian L, Arndt C, Tadayoni R, Soudry-Faure A, Creuzot Garcher CP. Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents, and Age-Related Macular Degeneration Study: A Randomized Controlled Trial for Submacular Hemorrhage Secondary to Age-Related Macular Degeneration. Ophthalmology. 2023 Sep;130(9):947-957. doi: 10.1016/j.ophtha.2023.04.014. Epub 2023 Apr 22. PubMed 37088447 ↗
  • Gabrielle PH, Eid P, Aho LS, Kodjikian L, Souied E, Uzzan J, Conart JB, Delyfer MN, Creuzot-Garcher C. Prognostic Factors in Patients With Submacular Haemorrhage Complicating Age-Related Macular Degeneration: A Post Hoc Analysis of the STAR Study. Clin Exp Ophthalmol. 2026 May-Jun;54(4):492-499. doi: 10.1111/ceo.70094. Epub 2026 Feb 24. PubMed 41734820 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02557451
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Sep 23, 2015
Start date
Apr 28, 2016
Primary completion
May 5, 2020
Last update
Feb 9, 2026
View the source record on ClinicalTrials.gov ↗

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