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Ronald P. Danis, Srinivas Sadda, Jenny Jiao, Xiao-Yan Li, Scott M. Whitcup; Central Retinal Thickness Following Dexamethasone Intravitreal Implant Treatment in Patients With Macular Edema Due to Branch or Central Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2011;52(14):1260.
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© ARVO (1962-2015); The Authors (2016-present)
We report the changes in central retinal thickness (CRT) from a 6-month multicenter study that was carried out in 167 clinical centers that evaluated dexamethasone intravitreal implant (DEX implant) for the treatment of macular edema (ME) due to branch or central retinal vein occlusion (RVO).
Subjects were randomized to DEX implant 0.7 mg (n = 427) or sham procedure (n = 426). At day 180, eligible patients (BCVA of < 84 letters or CRT of > 250 µm) received DEX and were followed in an open-label, 6-month extension study. Overall, 341 of 427 DEX implant patients received the second DEX implant (DEX/DEX implant) while 326 of 426 sham patients received the first DEX implant (sham/DEX implant) at month 6. CRT was measured by OCT at baseline and months 3, 6, 9, and 12.
Mean decreases from baseline CRT in the DEX implant and sham groups were, respectively, 208 vs 85 µm at month 3 (P < .001) and 119 vs 119 µm at month 6. The decrease from baseline CRT at month 3 was significantly greater for both branch and central RVO patients who received DEX implant compared to those who received sham procedure (P < .001). Mean (SD) decrease from baseline CRT in the DEX/DEX implant and sham/DEX implant groups were, respectively, 207 vs 71 µm at month 3, 97 vs 102 µm at month 6, 263 vs 267 µm at month 9, and 166 vs 170 µm at month 12. During the first 6 months, the decrease from baseline CRT was significantly correlated with the increase in BCVA (month 3: slope = -0.013 letters/µm, P < .001; month 6: slope = -0.016 letters/µm, P < .001). Multiple linear regression analysis indicated that a difference in baseline CRT of 100 µm was correlated with changes in BCVA ranging from approximately 0.5 letters at day 20 to 1.5 letters at month 6 (P < .001).
DEX implant reduced CRT similarly after each treatment. The treatment effect on CRT was gone 6 months after implantation of DEX implant. Both baseline CRT and change from baseline CRT were significantly correlated with changes in BCVA.
Clinical Trial: :
http://www.clinicaltrials.gov 00168298 & 00168324
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