FRCRnet was the initiator of two national clinical trials funded by the 2017 Hospital Clinical Research Programme (PHRC) in the fields of diabetic retinopathy (TaLaDME protocol) and rare diseases (TELeMAC protocol).
TalaDME project
Photocoagulation of capillary macroaneurysms in addition to the standard treatment of macular oedema due to diabetic retinopathy
Summary:
Diabetic macular oedema (DMO) results from the hyperpermeability of retinal vessels leading to chronic extravasation of plasma components in the retina. It is the main cause of vision loss in people under 60 years of age. The prevalence of DMO in diabetic patients is about 5%. In France, given that there are 3.5 million diabetics, DMO therefore affects about 200,000 people. Current DMO treatment is based on repeated intravitreal injections of anti-VEGF or corticosteroids, which has been shown to be beneficial in large randomised studies. However, intravitreal injections have certain disadvantages: a schedule of monthly visits, the risk of endophthalmitis (0.02 - 0.1%), cataracts (in the case of steroids) and the costs (around €800 per injection). An average of nine anti-VEGF injections is required to achieve an optimal effect during the first year of treatment.
It has recently been shown that focal vascular abnormalities (capillary macroaneurysms) can play a central role in DMO. Indeed, their prevalence is estimated at about 30% of DMO cases. However, macroaneurysms may be difficult to detect by conventional imaging procedures, namely fluorescein angiography.
We have shown that indocyanin green (ICG) angiography combined with optical coherence tomography (OCT) markedly improves the detection of capillary macroaneurysms. We have therefore developed a procedure called targeted laser photocoagulation (IGTL), which combines the detection of macroaneurysms by ICG angiography, their photocoagulation by laser and the immediate post-laser verification of the effectiveness of the photothrombosis by OCT.
This study's main objective is to demonstrate that IGTL, in combination with conventional intravitreal anti-VEGF injection therapy, significantly reduces the number of injections needed during the first year of treatment versus the absence of IGTL, and also has no adverse clinical consequences on visual acuity.
Number of patients: 270
Duration of patient participation: 12 months
Number of centres: 10
Project scope: national
Main eligibility criteria:
- Be legally of age
- Have diabetic macular oedema due to a macroaneurysm
- Have decreased visual acuity
- Be affiliated to a social security scheme
TELeMAC project
Comparative multicenter randomized study of macular telangiectasia type 1 with aflibercept versus placebo
Summary:
Idiopathic juxtafoveal telangiectasia type 1 (Mac Tel 1) is a rare unilateral disease that mostly affects men before 50 years of age. No genetic characteristics or pathogenic mechanisms have so far been identified. Mac Tel 1 is characterised by microvascular telangiectasia and tortuous vessels in the macular capillary network on the temporal part of the fovea, which can be identified on fundus examination. In some cases, it may be associated with peripheral vascular changes, similar to manifestations of Coats' disease. Macular oedema, associated with vision loss, may also develop.
Macular oedema can be treated with different strategies although there is no consensus on this subject. Laser can be performed on abnormalities or ischemic areas, but it has questionable long-term efficacy and potential irreversible adverse effects. Recently, anti-VEGF (vascular endothelial growth factor) antibodies have been proposed to treat this macular oedema, as observed in vein occlusion or diabetic macular oedema. In limited studies, the first anti-VEGF agents (ranibizumab and bevacizumab) produced mixed results. More recently, authors have reported favourable results with aflibercept in patients who were refractory to other anti-VEGF agents. Indeed, a recent study reported good anatomical and functional results on macular oedema due to Mac Tel 1 in a non-comparative study.
The aim of this study is therefore to assess the efficacy of a 6-month treatment with aflibercept compared to a placebo in macular oedema due to Mac Tel 1.
Number of patients: 46
Duration of patient participation: 6 months
Number of centres: 15
Project scope: national
Main eligibility criteria:
- Be legally of age
- Have macular telangiectasia type 1 and macular oedema
- Have decreased visual acuity
- Be affiliated to a social security scheme
Participation in the studies
If you would like more information about one of our studies, please contact us via our contact form.