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Post hoc analysis of GENEVA data supports earlier treatment using implant
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 Julia A. Haller |
BOSTON - Early treatment may enhance visual outcomes for patients who receive a dexamethasone implant for macular edema due to branch retinal vein occlusion, a presenter here said.
At the American Society of Retina Specialists meeting, Julia A. Haller, MD, OSN Retina/Vitreous Board Member, reported on a retrospective analysis of data from the phase 3 GENEVA trials, which assessed Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan) compared with sham procedure.
"Macular edema duration is a significant predictor for best corrected visual acuity improvement in vein occlusion eyes. Subjects with less than or equal to 90 days duration exhibited greater improvement, and the results suggest that earlier treatment ... may provide greater clinical benefit," Dr. Haller said.
Shorter duration translated to an added BCVA gain of 3.4 letters for those treated with dexamethasone and 1.3 letters for sham therapy subjects.
Because the GENEVA trials were not designed to access a causal relationship between macular edema duration and patient outcomes, this analysis suggested only an association and not a causal relationship, Dr. Haller said. Moreover, the analysis was limited by potential recall bias regarding edema duration.
- Disclosure: Dr. Haller is a consultant for Allergan and Genentech.
The study concluded that retinal vein occlusion patients with macular edema of a duration shorter than 90 days obtained better visual outcomes with the dexamethasone implant than those with a longer duration of disease. At day 60, just after peak dexamethasone levels were reached, a statistically significant higher percentage of patients achieved at least a 15-letter improvement in best corrected visual acuity, as well as a larger mean BCVA improvement. Overall, throughout time points up to day 180, patients with macular edema for a shorter duration experienced better outcomes. A similar subgroup analysis was reported at the American Society for Retina Specialists meeting last year, for the CRUISE and BRAVO studies, in which patients with shorter duration did better with ranibizumab than those with longer duration.
In the era of grid laser for branch retinal vein occlusion, it was recommended to wait 3 months before initiating treatment. A delay was not thought to be detrimental to visual outcomes and allowed time for intraretinal hemorrhages to clear. The message, however, has changed; in the era of intravitreal pharmacotherapy, results show that patients treated earlier obtain better visual outcomes.
– Sophie J. Bakri, MD
Associate professor
of ophthalmology, Mayo Clinic
Disclosure: Dr. Bakri has served as a
consultant for Allergan.