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Prompt treatment with steroid implant improves outcomes in retinal vein occlusion patients
Using a dexamethasone intravitreal implant to promptly treat macular edema in eyes with retinal vein occlusion improved the likelihood of a positive outcome, according to a study.
“Of all of the predictors that were identified … only duration of [macular edema] is a modifiable risk factor that can be taken into account meaningfully when deciding on a course of treatment,” the study authors said.
Two identical, prospective, multicenter phase 3 clinical trials evaluated the effectiveness and safety of the Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan) in 690 patients with branch or central retinal vein occlusion.
Initially, 394 patients received the implant and 296 patients received a sham treatment. The patients who received the sham treatment were treated with the implant at the conclusion of a 6-month double-masked phase.
Researchers focused on outcomes of a 15-letter or more improvement in best corrected visual acuity, a BCVA of 69 letters or more (20/40 vision), a 200-µm or more reduction in central retinal thickness, and a central retinal thickness of 250 µm or less from initial time of treatment to 6 months or 12 months after treatment.
For every month increase in duration of macular edema, at 6 months postoperatively, there was a lower chance of achieving an improvement in vision of 15 letters or more (P < .001) or a reduction in central retinal thickness of 200 µm or more (P < .01). At 12 months, there was a lower chance of achieving an improvement in vision of 15 letters or more (P < .01), but there was no affect on central retinal thickness.
The duration of macular edema was significant in BRVO subjects but not in CRVO subjects.
Perspective
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The CRUISE and BRAVO ranibizumab FDA registration trials, as well as the GENEVA Ozurdex FDA registration trial, answered numerous questions that were important in the management of macular edema secondary to retinal vein occlusions. Keep in mind that it is incredibly unlikely that we will ever see another sham-controlled FDA registration trial given that we now have two FDA approved products for this condition. Therefore, it is imperative that we learn as much as possible from these three trials, especially to investigate outcomes after delaying treatment for 6 months compared to eyes that receive treatment at baseline.
Wei and colleagues investigated the effect of the duration of macular edema on clinical outcomes in eyes with retinal vein occlusion treated with Ozurdex. They found in the 6 month analysis that each 1 month increase in macular edema duration was associated with a significantly lower likelihood of achieving a BCVA improvement of 15 letters or more or a central retinal thickness reduction of 200 µm or more 6 months after treatment. Similar findings to this were observed in CRUISE and BRAVO.
The take home message from these studies is that the conventional wisdom of “observing” macular edema from retinal vein occlusion, especially with center involvement, should be revisited. The literature suggests that prompt treatment for retinal vein occlusion with intravitreal therapy may be associated with improved clinical outcomes.
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Ophthalmology. 2012;119(6):1190-1198.