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
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.
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.
Patients presenting subretinal haematoma linked to AMD
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:
surgery (vitrectomy - air - TPA) with injections of an antiangiogenic
Other: Surgery · Procedure: injections of an antiangiogenic
intravitreal injection of gas - TPA with injections of an antiangiogenic
Other: Intravitreal injections of gas · Procedure: injections of an antiangiogenic
Visual acuity measured on the ETDRS scale
Time frame: Change from inclusion at 3 months
Visual acuity measured on the ETDRS scale
Time frame: At 1 month and 6 months
Area of the scotoma presented by the patient according to the Amsler grid
Time frame: At 1 month, 3 months and 6 months
Quality of life using the VFQ-25 scale
Time frame: At 3 months and 6 months
Number of injections of an antiangiogenic at the end of the 6 months of treatment
Time frame: At 6 months
Number of patients with macular bleeding
Time frame: At 6 months
Area of hypoautofluorescence using the autofluorescence technique
Time frame: At 3 and 6 months
Complications rate
Time frame: At 6 months
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Dijon