Article

Expanded 2-Year Follow-up of Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema

Elman Retina Group, PA, Baltimore, Maryland, USA.
Ophthalmology (Impact Factor: 6.14). 04/2011; 118(4):609-14. DOI: 10.1016/j.ophtha.2010.12.033
Source: PubMed

ABSTRACT

To report expanded 2-year follow-up of a previously reported randomized trial evaluating intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME).
Multicenter, randomized clinical trial.
A total of 854 study eyes of 691 participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea.
Continuation of procedures previously reported for the randomized trial.
Best-corrected visual acuity and safety at the 2-year visit.
At the 2-year visit, compared with the sham + prompt laser group, the mean change in the visual acuity letter score from baseline was 3.7 letters greater in the ranibizumab + prompt laser group (95% confidence interval adjusted for multiple comparisons [aCI], -0.4 to +7.7), 5.8 letters greater in the ranibizumab + deferred laser group (95% aCI, +1.9 to +9.8), and 1.5 letters worse in the triamcinolone + prompt laser group (95% aCI, -5.5 to +2.4). After the 1- to 2-year visit in the ranibizumab + prompt or deferred laser groups, the median numbers of injections were 2 and 3 (potential maximum of 13), respectively. At the 2-year visit, the percentages of eyes with central subfield thickness ≥250 μm were 59% in the sham + prompt laser group, 43% in the ranibizumab + prompt laser group, 42% in the ranibizumab + deferred laser group, and 52% in the triamcinolone + prompt laser group. No systemic events attributable to study treatment were apparent. Three eyes in 3 (0.8%) of 375 participants had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group.
The expanded 2-year results reported are similar to results published previously and reinforce the conclusions originally reported: Ranibizumab should be considered for patients with DME and characteristics similar to those of the cohort in this clinical trial, including vision impairment with DME involving the center of the macula.

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Available from: Michael J Elman, Dec 24, 2013
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    • "The DRCR.net trial was funded by the US National Institute of Health and was a multicentre randomised (by eye rather than participant) to sham injection and prompt laser (í µí±› = 293), IVR and prompt laser (í µí±› = 187), IVR and deferred (≥24 weeks) laser (í µí±› = 188), or triamcinolone and prompt laser (í µí±› = 186). Only the results of 12-month follow-up were available for the NICE technology appraisal, although twoyear follow-up is now published [18]. Compared with the sham injection plus prompt laser group, the mean change in the visual acuity (ETDRS) letter score from baseline was 3.7 letters greater in the IVR plus prompt laser group, 5.8 letters greater in the IVR plus deferred laser group, and 1.5 letters worse in the triamcinolone plus prompt laser group. "
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