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Cazet-Supervielle Agathe, Nicolas Leveziel, Michèle Boissonnot; Intravitreal injections of ranibizumab with deferred laser grid laser photocoagulation for the treatment of diabetic macular edema with visual impairment: LLOMD study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1769.
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© ARVO (1962-2015); The Authors (2016-present)
The diabetic macular edema (DME) is the most common cause of central visual loss in diabetic patients. Intravitreal injections (IVT) of ranibizumab have been approved for the treatment of DME. However, around 10 ranibizumab IVTs are needed during the first year of treatment with ranibizumab alone (RESOLVE study). In this context, ranibizumab IVTs combined with macular laser may be beneficial to reduce the number of IVT. The aim of this study was to evaluate the efficacy of IVT associated with deferred laser grid for diabetic macular edema.
Prospective, monocentric open-label, uncontrolled phase 2 study.<br /> 30 patients with BCVA < 69 letters and CRT > 310m (OCT Cirrus Zeiss) due to DME were enrolled between October 2011 and July 2013. Patients were treated with ranibizumab 0.5 mg given for 3 months then with laser grid at month 4. During follow-up, a ranibizumab injection was performed every 2 months in case of BCVA decreased more than 5 letters.The number of reinjections, the best-corrected visual acuity (BCVA) and the central retinal thickness (CRT) were analysed at one year, of a strategy based on intravitreal ranibizumab injection associated with laser treatment in DME.<br />
46,7% of patients didn’t require a new IVT at 12 months. The mean number of IVT was 4,9. From baseline at 12 months, there was a mean gain of 8,5 letters of BCVA (p<0,001; IC 95% = 4,5 - 12,5). 73,3% of eyes gained > 5 letters. 46,7% of eyes gained > 10 letters. 33,3% of eyes gained > 15 letters at 12 months. The decrease in the average CRT was 78,9 m (p=0,014; IC95%= -16,8 - -140,9). The quality of life scores improved significantly for general health (p=0,030), general vision (p=0,001), near activities (p=0,040) and mental health (p=0,045). In the multifocal electroretinogram, there was a significant decrease of the RMS signal, of the amplitude of the P1 and of the N1 waves; the implicit time of the P1 wave was delayed. The low visual acuity at baseline was correlated with the need to reinject at least one time during the first year of treatment.
Adding macular grid to ranibizumab IVT at the 4th month appears promising in the treatment of DME. It seems to reduce the number of IVTs during the first year of treatment and consequently the economic burden of the treatment.
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