Intravitreal dexamethasone implant Ozurdex® in naïve and refractory patients with different subtypes of diabetic macular edema

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Background

Diabetic macular edema (DME) can be treated with different alternatives, among them Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) has demonstrated that may improve both central macular thickness (CMT) and best corrected visual acuity (BCVA). This study aimed to evaluate the effect of the intravitreal dexamethasone implant Ozurdex® in patients with different subtypes of diabetic macular edema over a 6-month follow-up period.

Methods

Eighty-four (29 naïve and 55 previously treated) eyes were included in this retrospective study. For each patient, the BCVA [Early Treatment Diabetic Retinopathy Study (ETDRS) charts] and macular thickness on optical coherence tomography (OCT) at baseline visit and within the 2nd, 4th, and 6th months of follow-up were obtained. The main outcomes measurements were the mean change in BCVA and in CMT with respect to the baseline value. The percentage of patients gaining ≥5 letters and ≥ 10 letters in BCVA was also analyzed. Results: A total of 84 eyes, 29 (34.5%) naïve and 55 (65.5%) non-naïve, from 69 patients were included in the study. BCVA at baseline was 58.8 (16.4) and 61.8 (11.6) in naïve and refractory patients, respectively, p = 0.4513. At every visit, BCVA significantly improved from baseline in naïve and non-naïve eyes ( p < 0.0001 and p = 0.0003, respectively; Friedman rank sum test). At baseline, the mean CMT was 466.2 (189.7) μm and 448.1 (110.7) μm in the naïve and non-naïve patients, respectively ( p = 0.5830); and decreased to 339.3 (92.5) μm and 357.5 (79.1) μm, respectively ( p = 0.0004 and p < 0.0001, respectively, Wilcoxon signed-rank test). The proportion of patients gaining ≥10 letters was significantly greater in the naïve group, p = 0.0199.

Conclusion

The intravitreal dexamethasone implant (Ozurdex) is effective for the treatment of diabetic macular edema, even in refractory cases that have failed to respond to previous therapies.

Related collections

Most cited references 26

Record: found
Abstract: found
Article: not found

Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant.

Mayssa Attar, Joan Chang, Derrick R. Robinson … (2010)

To determine the pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone (DEX) intravitreal implant (Ozurdex; Allergan, Inc.). Thirty-four male monkeys (Macaca fascicularis) received bilateral 0.7-mg DEX implants. Blood, vitreous humor, and retina samples were collected at predetermined intervals up to 270 days after administration. DEX was quantified by liquid chromatography-tandem mass spectrometry, and cytochrome P450 3A8 (CYP3A8) gene expression was analyzed by real-time reverse transcription-polymerase chain reaction. DEX was detected in the retina and vitreous humor for 6 months, with peak concentrations during the first 2 months. After 6 months, DEX was below the limit of quantitation. The C(max) (T(max)) and AUC for the retina were 1110 ng/g (day 60) and 47,200 ng · d/g, and for the vitreous humor were 213 ng/mL (day 60) and 11,300 ng · d/mL, respectively. The C(max) (T(max)) of DEX in plasma was 1.11 ng/mL (day 60). Compared with the level in the control eyes (no DEX implant), CYP3A8 expression in the retina was upregulated threefold up to 6 months after injection of the implant (0.969 ± 0.0565 vs. 3.07 ± 0.438; P < 0.05 up to 2-month samples). The in vivo release profile of the DEX implant in an animal eye was similar to the pharmacokinetics achieved with pulse administration of corticosteroids (high initial drug concentration, followed by a prolonged period of low concentration). These results are consistent with those in clinical studies supporting the use of the DEX implant for the extended management of posterior segment diseases.

0 comments Cited 173 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients.

Xiao Li, Jean-Lou Cochon, Scott Whitcup … (2011)

To evaluate the safety and efficacy of Ozurdex (dexamethasone intravitreal implant) 0.7 mg in the treatment of diabetic macular edema in vitrectomized eyes. This was a prospective, multicenter, open-label, 26-week study. Fifty-five patients with treatment-resistant diabetic macular edema and a history of previous pars plana vitrectomy in the study eye received a single intravitreal injection of 0.7-mg dexamethasone intravitreal implant. The primary efficacy outcome measure was the change in central retinal thickness from baseline to Week 26 measured by optical coherence tomography. The mean age of patients was 62 years. The mean duration of diabetic macular edema was 43 months. The mean (95% confidence interval) change from baseline central retinal thickness (403 μm) was -156 μm (-190, -122 μm) at Week 8 (P < 0.001) and -39 μm (-65, -13 μm) at Week 26 (P = 0.004). The mean (95% CI) increase in best-corrected visual acuity from baseline (54.5 letters) was 6.0 letters (3.9, 8.1 letters) at Week 8 (P < 0.001) and 3.0 letters (0.1, 6.0 letters) at Week 26 (P = 0.046). At Week 8, 30.4% of patients had gained ≥10 letters in best-corrected visual acuity. Conjunctival hemorrhage, conjunctival hyperemia, eye pain, and increased intraocular pressure were the most common adverse events. Treatment with dexamethasone intravitreal implant led to statistically and clinically significant improvements in both vision and vascular leakage from diabetic macular edema in difficult-to-treat vitrectomized eyes and had an acceptable safety profile.

0 comments Cited 118 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Optical coherence tomographic patterns of diabetic macular edema.

Jeffrey Smith, Peter Kaiser, Han-Sung Kim (2006)

To describe various morphologic patterns of diabetic macular edema (DME) demonstrated by optical coherence tomography (OCT) and correlate them with visual acuity. Retrospective, observational, case series. A retrospective review of all patients with DME who underwent OCT evaluation and met the study inclusion criteria between May 1998 and December 2002 at the Cole Eye Institute was performed. The OCT scans were evaluated for the presence of diffuse retinal thickening (DRT), cystoid macular edema (CME), posterior hyaloidal traction (PHT), serous retinal detachment (SRD), and traction retinal detachment (TRD). Additionally, the retinal thickness was measured and visual acuity evaluated. Two hundred seventy-six OCT scans of 164 eyes of 119 patients were identified. OCT revealed five morphologic patterns of DME: DRT (269, 97%), CME (152, 55%), SRD without PHT (19, 7.0%), PHT without TRD (35, 12.7%), and PHT with TRD (8, 2.9%). Mean retinal thickness varied depending on the morphologic pattern. The mean visual acuities (Snellen equivalent) also varied between groups. Increasing retinal thickness in all patterns was significantly correlated with worse visual acuity (P < .005). The OCT patterns containing CME (P = .01) and PHT without TRD (P = .02) were also significantly associated with worse vision. DME exhibits at least five different morphologic patterns on OCT. There is a significant correlation between retinal thickness and visual acuity.

0 comments Cited 67 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Contributors

Verónica Castro-Navarro: +34963131800 , veronicacastronavarro@gmail.com

Enrique Cervera-Taulet: ecervera@ono.com

Catalina Navarro-Palop: cnavarropalop@gmail.com

Clara Monferrer-Adsuara: clara_cma@hotmail.com

Laura Hernández-Bel: laura_hernandez_bel@hotmail.com

Journal

Journal ID (nlm-ta): BMC Ophthalmol

Journal ID (iso-abbrev): BMC Ophthalmol

Title: BMC Ophthalmology

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2415

Publication date (Electronic): 11 January 2019

Publication date PMC-release: 11 January 2019

Publication date Collection: 2019

Volume: 19

Electronic Location Identifier: 15

Affiliations

[1 ]ISNI 0000 0004 1770 977X, GRID grid.106023.6, University General Hospital of Valencia, ; Avenida Tres Cruces S/N, 46015 Valencia, Spain

[2 ]Ophthalmology Department, Avenida Tres Cruces S/N, CP/46015 Valencia, Spain

Article

Publisher ID: 1022

DOI: 10.1186/s12886-018-1022-9

PMC ID: 6330395

PubMed ID: 30634940

SO-VID: 3115bed0-9d03-42b6-9189-873455306c07

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.