Retinal Physician

JAN-FEB 2017

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R E T I N A L P H Y S I C I A N | J A N U A R Y / F E B R U A R Y 2 0 1 7 47 47 R E T I N A L P H Y S I C I A N . C O M | J A N U A R Y / F E B R U A R Y 2 0 1 7 the percentage of patients achieving ≥15-ETDRS letters of improvement at study completion. Compared with sham-treated patients, patients receiv- ing the dexamethasone implant (either dose) had an approximately 12-month delay in two-step DR progres- sion (36 months vs 24 months). 17 e 10th percentile of the time to two-step DR improvement occurred at 13 months in the low-dose group vs 24 months for the patients receiving sham or the high-dose implant. Cataract formation and intraocular pressure elevation were the two most common side effects. Fluocinolone Acetonide Implant e fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences, Alpharetta, GA) is an injectable, nonerodible, corticosteroid implant that has been shown to provide treatment benefit for at least three years. is implant represents one of the newest additions to the DR treatment armamentarium and holds promise for patients with treatment-resistant DME. e FAME study group 8 investigated a low- (0.2 µg/ day) and high-dose (0.5 µg/day) fluocinolone implant in patients with persistent DME despite at least one macular laser treatment. A ≥2-step improvement in DRSS occurred in 13.7% of the patients receiving the low-dose implant, compared to only 8.9% in the sham group. e side effects of the fluocinolone implant included cataract formation and elevated IOP requiring tube shunt surgery in just under 5% of patients receiving the low-dose implant vs 8% in the high-dose group. is finding high- lights the importance of careful selection criteria for this implant, and recent work has focused on providing patient selection guidelines based on the FAME trial data. 18 SUMMARY AND FUTURE DIRECTIONS In summary, the single most important factor for slowing DR progression remains aggressive blood glucose control, with a target A1C of less than 7%. Continuing to educate our patients on the importance of blood glucose, blood pressure, and lipid control remains paramount, even in the age of anti-VEGF therapy. However, the importance of the early identification and treatment of DME with anti-VEGF agents should not be understated. e data strongly support early, aggres- sive treatment, with a corresponding stabilization, and in many cases reversal, of retinopathy progression. After this initial intensive treatment period, the data suggest that de- escalation of anti-VEGF therapy is possible without com- promising initial VA gains. e pathophysiology underlying the ocular response to anti-VEGF is only partially understood, and data utilizing new imaging techniques, including OCT angiography and ultrawidefield FA, may provide additional answers to help guide treatment. Steroid therapy may play a role as a second-line therapy in patients with anti-VEGF resistant DME. Sustained- release steroid formations hold promise, particularly for pseudophakic patients who have passed a steroid IOP challenge. Additional research is needed to help identify ideal treatment regimens for patients earlier in their dis- ease courses. RP REFERENCES 1. Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthal- mology. 2012;119:789-801. 2. Boyer DS, Nguyen QD, Brown DM, et al. Outcomes with as-needed ranibi- zumab after initial monthly therapy: Long-term outcomes of the phase III RIDE and RISE Trials. Ophthalmology. 2015;122:2504-2413. 3. Diabetic Retinopathy Clinical Research Network; Elman MJ, Aiello LP, Beck RW, et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Oph- thalmology. 2010;117:1064-1077. 4. Bressler SB, Qin H, Melia M, et al. Exploratory analysis of the effect of intra- vitreal ranibizumab or triamcinolone on worsening of diabetic retinopathy in a randomized clinical trial. JAMA Ophthalmol. 2013;131:1033-1040. 5. Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal aflibercept for dia- betic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122(10):2044-2052. 6. Diabetic Retinopathy Clinical Research Network. A randomized trial compar- ing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2008;115:1447-1449. 7. Boyer DS, Yoon YH, Belfort R Jr, et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014;121:1904-1914. 8. Campochiaro PA, Brown DM, Pearson A, et al. Sustained delivery fluocino- lone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119:2125-2132. 9. Ip MS, Domalpally A, Sun JK, et al. Long-term effects of therapy with ranibizumab on diabetic retinopathy severity and baseline risk factors for worsening retinopathy. Ophthalmology. 2015;122:367-374. 10. Writing Committee for the Diabetic Retinopathy Clinical Research Network; Gross JG, Glassman AR, Jampol LM, et al. Panretinal photocoagulation vs intravitreous ranibizumab for proliferative diabetic retinopathy: a randomized clinical trial. JAMA. 2015;314:2137-2146. 11. Bressler SB. Panretinal photocoagulation versus intravitreous ranibizumab for proliferative diabetic retinopathy (PDR): worsening of PDR. Paper pre- sented at: Annual meeting of the Retina Society; San Diego, CA; September 16, 2016. 12. Singh R. Association between baseline characteristics and changes in diabetic retinopathy severity scale (DRSS) score: analyses from the VISTA and VIVID studies. Paper presented at: Annual meeting of the Retina Society; San Diego, CA; September 15, 2016. 13. Michaelides M, Kaines A, Hamilton RD, et al. A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2. Ophthalmology. 2010;117:1078-1086. 14. Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, bevacizumab, or ranibi- zumab for diabetic macular edema: two-year results from a comparative ef- fectiveness randomized clinical trial. Ophthalmology. 2016;123:1351-1359. 15. Campochiaro PA, Wykoff CC, Shapiro H, et al. Neutralization of vascular en- dothelial growth factor slows progression of retinal nonperfusion in patients with diabetic macular edema. Ophthalmology. 2014;121:1783-1789. 16. Lee J, Moon BG, Cho AR, et al. Optical coherence tomography angiography of DME and its association with anti-VEGF treatment response. Ophthalmol- ogy. 2016;123:2368-2375. 17. Danis RP, Sadda S, Li XY, et al. Anatomical effects of dexamethasone intravitreal implant in diabetic macular oedema: a pooled analysis of 3-year phase III trials. 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