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


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.

Download full-text


Available from: Michael J Elman, Dec 24, 2013
  • Source
    • "With the introduction of vascular endothelial growth factor inhibitors (anti-VEGF), the management of clinically significant diabetic macular oedema (CSMO) has progressively shifted to the use of intravitreal drug therapies, usually injected every 4–6 weeks.1–8 To limit the treatment burden associated with frequent anti-VEGF injections, combination regimens with macular laser photocoagulation and anti-VEGF drugs have been investigated in multiple studies to determine if they might result in fewer required interventions.3 5–9 However, attempts to limit the number of injections have not produced comparable visual outcomes.3–7 10–12 Two potential limitations of these studies include the variable timing and application of laser therapy. "
    [Show abstract] [Hide abstract]
    ABSTRACT: To evaluate the efficacy of a standardised combination therapy for clinically significant diabetic macular oedema using bevacizumab injections followed by navigated laser photocoagulation to stabilise retinal thickness. In this pilot study we retrospectively reviewed charts and imaging of 23 eyes treated with the standardised combination regimen. Eyes initially received monthly bevacizumab injections, followed by navigated laser photocoagulation when central retinal thickness (CRT) was <440 µm. Patients were then followed monthly for 12 months. At the time of navigated laser after bevacizumab treatment mean vision gain was +10.4 Early Treatment Diabetic Retinopathy Study letters (p<0.01) and CRT reduction was 146 µm (p<0.001). At 12 months from baseline, the vision gain remained stable at +10.6 Early Treatment Diabetic Retinopathy Study letters (p<0.01), and CRT reduction was stable at 137 µm (p<0.001). At 12 months from laser, the vision gain was 7.8 letters from baseline (p<0.01), with no significant change compared with the gain at 12 months from baseline (p=0.108). At 12 months from laser, CRT reduction was 125 µm from baseline (p<0.001), with no significant change compared with CRT reduction at 12 months from baseline (p=0.601). Total injections needed were 4.4 from baseline to month 12, with 1.3 reinjection needed after laser. 57% of the eyes didn't require injections after laser, while 43% needed two additional injections. Standardised combination therapy using bevacizumab injections followed by navigated laser treatment for clinically significant diabetic macular oedema demonstrated significant visual gain and CRT reduction after bevacizumab treatment and stabilisation after navigated laser up to 12 months. The number of injections required in 12 months was lower than reported in previous combination studies.
    The British journal of ophthalmology 04/2014; 98(8). DOI:10.1136/bjophthalmol-2013-304488 · 2.98 Impact Factor
  • Source
    • "Two-year incidence of nonfatal myocardial infarction was 3% in the laser alone group, 1% in the ranibizumab-laser group, and 3% in the TA-laser group. Any cardiovascular event, as defined by Antiplatelet Trialists' Collaboration (ATC), occurred in the 12% in the laser alone group, 5% in the ranibizumab-laser group, and 6% in the TA-laser group [61]. Reports of systemic adverse events were similar between the SCORE-BRVO and CRVO trial groups. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Diabetic macular edema (DME), pseudophakic cystoid macular edema (CME), age-related macular degeneration (AMD), retinal vascular occlusion (RVO), and uveitis are ocular conditions related to severe visual impairment worldwide. Corticosteroids have been widely used in the treatment of these retinal diseases, due to their well-known antiangiogenic, antiedematous, and anti-inflammatory properties. Intravitreal steroids have emerged as novel and essential tools in the ophthalmologist's armamentarium, allowing for maximization of drug efficacy and limited risk of systemic side effects. Recent advances in ocular drug delivery methods led to the development of intraocular implants, which help to provide prolonged treatment with controlled drug release. Moreover, they may add some potential advantages over traditional intraocular injections by delivering certain rates of drug directly to the site of action, amplifying the drug's half-life, contributing in the minimization of peak plasma levels of the drug, and avoiding the side effects associated with repeated intravitreal injections. The purpose of this review is to provide an update on the use of intravitreal steroids as a treatment option for a variety of retinal diseases and to review the current literature considering their properties, safety, and adverse events.
    The Scientific World Journal 01/2014; 2014(12):989501. DOI:10.1155/2014/989501 · 1.73 Impact Factor
  • Source
    • "Similarly, the RESTORE study (ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema) and the DRCR.net study have shown that ranibizumab monotherapy or ranibizumab-deferred laser treatment was superior to triamcinolone monotherapy or standard laser alone with respect to BCVA outcomes over 3 years, likely due to earlier dry maculas (followed by serial OCT images) as a result of treatment with anti-vascular endothelial growth factor.23,24 "
    [Show abstract] [Hide abstract]
    ABSTRACT: The development of spectral-domain optical coherence tomography (OCT) allows for the highest commercially available resolution of in vivo retinal anatomic details to date. The ability to see the macula with ever increasing detail is dramatically improving our understanding of the pathogenesis of retinal disease. However, the only prospective study that partially evaluated spectral-domain OCT versus time-domain OCT failed to show any clinical benefit of increased OCT resolution. Clinical outcomes, eg, best-corrected visual acuity, central macular thickness and number of injections, with "newer" OCT technologies remain an unproven advantage.
    Clinical ophthalmology (Auckland, N.Z.) 10/2013; 7:2085-2089. DOI:10.2147/OPTH.S49552
Show more