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Chris Lohmann, Jessica Voegeler, Sandra Liakopoulos, Peter Wiedemann, Georg Spital, Gabriele Lang, ; Double-Masked Trial Demonstrates Superiority Of Combined Ranibizumab Plus Laser Versus Laser In Patients With Diabetic Macular Edema With Or Without Proliferative Diabetic Retinopathy. Invest. Ophthalmol. Vis. Sci. 2013;54(15):1239.
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Diabetic Macular Edema (DME) and proliferative diabetic retinopathy (PDR) are common consequences of diabetic retinopathy. anti-VEGF therapy alone Or combined with laser showed convincing results in for DME, while outcome in patients with PDR remains unclear.
In the RELATION study, a multicenter, 12-months, two-armed, double-masked, parallel-group, active controlled clinical trial, patients with visual impairment die to DME were randomized 2:1 to ranibizumab in combination with focal/grid laser photocoagulation (combined group) Or focal/grid laser photocoagulation combined with sham injections (laser group) with a follow-up of up to 12 months. After initial treatment starting at baseline with laser and 4 monthly ranibizumab/sham injections, treament was given as needed (PRN). Visual acuity (VA) was tested with ETDRS charts by certified VA.-assessors. Anatomical changes were graded by central reading center assessing OCT (time Or spectral domain), fluorescence angiography (FLA) and fundus photography (FP). A subgroup of patients with concomitant PDR was included receiving additional panretinal laser photocoagulation (PRP) at baseline, then treatment as randomized.
Of 128 patients, 85 were randomized to the combined group and 43 to the laser group. BCVA in the combined group was significantly better than BCVA in the laser group at final follow-up (mean change from baseline +6.5 vs +1.4 ETDRS letters, p=0.001, LOCF method). 80% of Centers used SD-OCT instruments. The reduction of total retinal volume [within 6 mm ETDRS grid mm3] in OCT was significantly higher in the combination group than in the laser group [mean change from baseline -1.174 vs -0.501 mm3, FAS, LOCF]. 27 patients had PDR at baseline (20 in combined and 7 in laser group). Presence of PDR had no significant effect on BCVA outcome. eight (40%) patients with PDR in the combined group but none of the PDR patients in the laser group showed regression of PDR during follow-up. The adverse Event profile was similar to previous studies in NPDR and PDR patients.
Results of this clinical trial show that combined therapy of ranibizumab and laser yielded better outcomes on BCVA and CRT than laser monotherapy in eyes with DME, also in eyes with PDR. Combination of laser with ranibizumab may result in regression of PDR
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