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

Abstract

Objective 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). Design Multicenter, randomized clinical trial. Participants Eight hundred and fifty four study eyes of 691 participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea. Methods Continuation of procedures previously reported for the randomized trial. Main Outcome Measures Best-corrected visual acuity and safety at the 2-year visit. Results At the 2-year visit, compared with the sham plus prompt laser group, the mean change in the visual acuity letter score from baseline was 3.7 letters greater in the ranibizumab plus prompt laser group (95% confidence interval adjusted for multiple comparisons [aCI]: -0.4 to +7.7) l, 5.8 letters greater in the ranibizumab plus deferred laser group (95% aCI: +1.9 to +9.8) and 1.5 letters worse in the triamcinolone plus prompt laser group (95% aCI : -5.5 to +2.4). After the 1- through the 2-year visit in the ranibizumab with 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 while elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone+prompt laser group. Conclusions The expanded 2-year results reported herein are similar to results published previously and reinforce the conclusions originally reported, that ranibizumab should be considered for patients with DME and characteristics similar to the cohort in this clinical trial, including vision impairment with DME involving the center of the macula.

The RELATION study: efficacy and safety of ranibizumab combined with laser photocoagulation treatment versus laser monotherapy in NPDR and PDR patients with diabetic macular oedema

“…Although direct comparisons cannot be made considering the differences in study design and patient population, the results are nevertheless consistent with the findings from previous studies comparing the combination of ranibizumab plus laser versus laser monotherapy (Elman et al. 2010, 2011; Mitchell et al. 2011; Nguyen et al.…”

New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel

“…Nevertheless, a small group of laser-treated patients (21%) in the DRCR.net protocol I study did achieve a 15-letter improvement in VA at 2 years, suggesting a delayed benefit. 11 Notwithstanding the importance of preventing further vision loss, there was until recently an unmet medical need for therapies that could restore VA in patients with DME who had visual impairment.…”

“…From week 16, retreatment was guided by predefined VA and optical coherence tomography (OCT) criteria, but was at investigator discretion. The study has a 5-year follow-up period; to date, data for 1-10 and 2-year outcomes 11 are reported. Mean BCVA change from baseline to year 1 was significantly better with ranibizumab in combination with either prompt or deferred laser therapy than with laser monotherapy (Table 1).…”

A review of therapies for diabetic macular oedema and rationale for combination therapy

“…Several pharmacologic agents are now available for the treatment of DMO including anti-VEGF agents [36][37][38][39][40][41] and corticosteroids. 36,[42][43][44][45][46][47][48] These treatments are summarised in Table 1.…”

“…36,[42][43][44][45][46][47][48] These treatments are summarised in Table 1. These treatments are particularly useful in eyes with centre-involving DMO.…”