A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema

Callanan, David; Loewenstein, Anat; Patel, Sunil; Massin, Pascale; Corcóstegui, Borja; Li, Xiaoyan; Jiao, Jenny; Hashad, Yehia; Whitcup, Scott M.

doi:10.1007/s00417-016-3472-1

Cited by 89 publications

(98 citation statements)

References 33 publications

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“…Both treatments are well tolerated and improved BCVA and anatomic outcomes in patients with DME [13]. The combination of the 2 treat- ments can be of greater benefit to the patient, acting from the initial stages of the disease on the various mechanisms involved in its development, minimizing the possibility of monotherapy long-term side effects, and decreasing the amount of total injections required.…”

Section: Discussionmentioning

confidence: 99%

Sequential Dexamethasone and Aflibercept Treatment in Patients with Diabetic Macular Edema: Structural and Functional Outcomes at 52 Weeks

et al. 2018

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Objective: The aim of this paper is to compare intravitreous aflibercept versus dexamethasone implant followed by aflibercept (sequential treatment group) in patients with diabetic macular edema (DME). Methods: We conducted an observational retrospective study in naïve DME patients, 15 treated only with aflibercept (a monthly injection for the first 5 consecutive doses, followed by an injection every 2 months), and 15 treated with a single dexamethasone implant followed by bimonthly aflibercept. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and qualitative features as well as adverse events were assessed at baseline and at 2, 6, and 12 months. Results: BCVA increased from 70.8 ± 4.1 to 83.5 ± 2.7 letters with aflibercept and from 75.6 ± 2.7 to 86.5 ± 2.5 with sequential treatment (p = 0.551). CMT decreased from 411 ± 26.1 to 288.1 ± 10.5 with aflibercept and from 411.4 ± 24.3 to 260.8 ± 17.9 in the sequential treatment group. The differences between the 2 groups, in terms of visual gain and decreased MT, were not statistically significant (p > 0.05). Nine and 6 injections and 9 and 7 monitoring visits were performed. Conclusion: Sequential treatment in DME, starting with dexamethasone and followed by aflibercept, is a promising alternative that can reduce the treatment burden in the first year without statistically significant differences in terms of visual gain and decreased MT compared to aflibercept only.

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Section: Discussionmentioning

confidence: 99%

Sequential Dexamethasone and Aflibercept Treatment in Patients with Diabetic Macular Edema: Structural and Functional Outcomes at 52 Weeks

et al. 2018

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“…A direct comparison between the dexamethasone implant and ranibizumab (0.5 mg) has been published recently [3]. In this study, the dexamethasone implant injected in a fixed regimen every 5 months was compared with ranibizumab given monthly for at least the first three assessments.…”

Section: Comparison Of the Dexamethasone Implant And Anti-vegf Therapmentioning

confidence: 99%

“…Thus, different regimens have been used that reduce the number of injections and medical visits, although they are often accompanied by a decrease in efficiency compared to more intensive treatments. By contrast, the fixed regimens employed with the dexamethasone implant in clinical trials [2, 3] may not render optimal clinical outcomes, and a pro re nata approach has been suggested to try to maximize the functional results while minimizing the burden of visits [4]. …”

Section: Introductionmentioning

confidence: 99%

Clinical Decision-Making when Treating Diabetic Macular Edema Patients with Dexamethasone Intravitreal Implants

et al. 2018

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Diabetes mellitus (DM) is a metabolic disease frequently associated with comorbidities that include diabetic macular edema (DME). The current medical approach to treating DME involves intravitreal injections with either anti-vascular endothelial growth factors or steroids. However, the burden associated with intravitreal injections and DM-derived complications is high, underlining the need to find optimal treatment regimens. In this article we describe the considerations we apply when treating DME patients with dexamethasone intravitreal implants (Ozurdex®), particularly those that influence the clinical decision-making process during the follow-up period. These considerations are based both on the available medical literature and on our clinical experience following the use of these implants in this type of patient, the goal being to optimize the number of injections and the clinical outcome of this therapy. We also provide a general overview of the pathophysiology of DME, highlighting the inflammatory component as a rationale to use steroids in these patients.

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“…For example, the FAME Study reported that a 140-μm reduction of the CRT was obtained 6 months after treatment with fluocinolone acetonide vitreous inserts [23, 24]. This led to an early and rapid reduction of the CRT and improvement of the BCVA in DME patients [25].…”

Section: Discussionmentioning

confidence: 99%

Short-Term Results of Intravitreal Triamcinolone Acetonide Combined with Cataract Surgery for Diabetic Macular Edema in Japan: In the Era of Anti-Vascular Endothelial Growth Factor Therapy

et al. 2018

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Purpose: To evaluate the effectiveness of an intravitreal triamcinolone acetonide injection (IVTA) combined with cataract surgery for diabetic macular edema (DME) resistant to anti-vascular endothelial growth factor (anti-VEGF) therapy. Procedure: IVTA combined with cataract surgery was performed on 29 eyes of patients with DME (aged 70.5 ± 6.2 years) who were refractive to anti-VEGF treatments. The visual acuity, central retinal thickness (CRT), and the central retinal sensitivity were assessed at 1, 4, 12, and 24 weeks after the treatment. Results: The visual acuity improved significantly from 0.49 ± 0.30 logMAR units to 0.35 ± 0.33 logMAR units at 24 weeks after the treatment (p < 0.05; repeated ANOVA). The CRT decreased significantly from 435.1 ± 112.3 μm to 350.8 ± 123.3 μm at 12 weeks after the treatment (p < 0.05). The retinal sensitivity threshold also improved significantly from 18.2 ± 4.3 dB to 20.4 ± 3.8 dB at 4 weeks after the treatment (p < 0.05). Conclusions: IVTA combined with cataract surgery is effective for successful treatment of eyes with DME refractive to anti-VEGF therapy.

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A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema

Cited by 89 publications

References 33 publications

Sequential Dexamethasone and Aflibercept Treatment in Patients with Diabetic Macular Edema: Structural and Functional Outcomes at 52 Weeks

Sequential Dexamethasone and Aflibercept Treatment in Patients with Diabetic Macular Edema: Structural and Functional Outcomes at 52 Weeks

Clinical Decision-Making when Treating Diabetic Macular Edema Patients with Dexamethasone Intravitreal Implants

Short-Term Results of Intravitreal Triamcinolone Acetonide Combined with Cataract Surgery for Diabetic Macular Edema in Japan: In the Era of Anti-Vascular Endothelial Growth Factor Therapy

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