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David G. Miller, Diabetic Retinopathy Clinical Research Network; Exploratory Analysis of Diabetic Retinopathy Worsening (Progression) at 1 Year and 3 Years in a Randomized Clinical Trial Evaluating Ranibizumab and Triamcinolone. Invest. Ophthalmol. Vis. Sci. 2012;53(14):366.
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Evaluate effect of intravitreal ranibizumab or intravitreal triamcinolone acetonide on worsening (progression) of diabetic retinopathy.
Exploratory analysis was performed on subjects with diabetic macular edema randomly assigned to sham+prompt laser, intravitreal 0.5-mg ranibizumab+prompt laser, intravitreal 0.5-mg ranibizumab+deferred (≥24 weeks) laser, or 4-mg intravitreal triamcinolone+prompt laser. Fundus photographs were obtained at baseline, 1 year, and 1 additional time between 1.5 and 3 years. Progression of retinopathy was defined as worsening from non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) (NPDR eyes only), or occurrence of panretinal photocoagulation, or occurrence of vitreous hemorrhage, or worsening of diabetic retinopathy severity level by at least 2 levels (NPDR eyes only). Cumulative probabilities were calculated using the life-table method. P values for the comparison of theranibizumab or triamcinolone groups with sham+prompt laser, adjusted for baseline retinopathy severity level and baseline visual acuity, were computed using proportional hazards regression. Results through 1 year are provided.
For eyes without PDR at baseline (N = 538), the cumulative probability with worsening was 10% (sham+prompt laser), 4% (ranibizumab+prompt laser, P = 0.04), 4% (ranibizumab+deferred laser, P = 0.06), and 4% (triamcinolone+prompt laser, P = 0.05). For eyes with PDR at baseline (N = 254), the cumulative probability with worsening was 20% (laser), 9% ranibizumab+prompt laser, P = 0.08), 2% (ranibizumab+deferred laser, P = 0.03), and 5% (triamcinolone+prompt laser, P<0.01).
Intravitreal ranibizumab+prompt or deferred laser as well as intravitreal triamcinolone+prompt laser appear to reduce the risk of worsening of diabetic retinopathy in eyes with NPDR or PDR. These results suggest that use of these drugs to prevent worsening of diabetic retinopathy is worth further investigation. Given the exploratory nature of these analyses, use of these treatments to reduce the probability of worsening of diabetic retinopathy is not warranted at this time.
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