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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
91
CHU de BESANCON
Besançon, France
CHU de Bordeaux
Bordeaux, France
CH de COLMAR
Colmar, France
CHI de CRETEIL
Créteil, France
CHU de DIJON
Dijon, France
CHU de GRENOBLE
Grenoble, France
HCL - Hôpital de la Croix-Rousse
Lyon, France
CHR de METZ-THIONVILLE
Metz, France
CH de MULHOUSE
Mulhouse, France
CH de NEVERS
Nevers, France
...and 7 more locations
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
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