Comparison of dexamethasone intravitreal implant with intravitreal anti-VEGF injections for the treatment of macular edema secondary to branch retinal vein occlusion

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Abstract

Background:

This meta-analysis compared the efficacy and safety of dexamethasone intravitreal implant (DEX) and anti-vascular endothelial growth factor (anti-VEGF) in the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

Methods:

The PubMed, Embase, Cochrane Library, and Web of Science databases were comprehensively searched for published studies comparing DEX with anti-VEGF for the treatment of ME caused by BRVO. Outcomes of the selected studies included best-corrected visual acuity (BCVA), central macular thickness (CMT), and adverse events. Review Manager (RevMan) 5.3 was used to analyze the data.

Results:

Six trials comparing the efficacy and safety of DEX with anti-VEGF were included in this meta-analysis. At 1 month, DEX achieved a mean BCVA superior to that achieved by anti-VEGF (MD = −0.11, P < .0001), in addition to a superior mean BCVA change (MD = −0.35, P < .00001). At 3 months, the mean BCVA showed a significant difference (MD = −0.06, P = .03) between DEX and anti-VEGF treatment, while the mean BCVA change was similar to that with anti-VEGF treatment (MD = −0.06, P = .11). However, neither mean BCVA nor mean BCVA change showed a significant difference between DEX and anti-VEGF treatment at 6 months (MD = 0.08, P = .06; MD = 0.06, P = .43, respectively). Mean CMT and mean CMT change were significantly lower in the DEX group than in the anti-VEGF group at 1 month (MD = −53.63 μm, P < .00001; MD = −60.1 μm, P = .005, respectively). However, at 3 months, mean CMT and mean CMT change were similar between DEX and anti-VEGF treatment (MD = 17.4 μ, P = .74; MD = 18.01 μm, P = .72, respectively). Although mean CMT in the anti-VEGF group was not significantly lower than that in the DEX group at 6 months (MD = 55.53, P = .07), the mean CMT change from baseline achieved by the anti-VEGF treatment was significantly superior to that obtained with DEX (MD = 75.53, P = .0002). Concerning adverse events, no statistically significant differences were observed in the incidence of cataract (OR = 4.25, P = .07), but the use of DEX led to a higher risk of intraocular pressure elevation compared with anti-VEGF treatment (OR = 12.04, P = .006).

Conclusions:

Our results show that visual acuity recovery and CMT were better in the DEX group than in the anti-VEGF group after 1 and 3 months, although the difference in CMT at 3 months was not significant. However, there were no significant differences in terms of visual acuity and CMT between the two groups after 6 months of follow-up. Therefore, DEX may be recommended as the first treatment option in ME associated with BRVO.

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Most cited references 23

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Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results.

Julia A Haller, Francesco Bandello, Rubens Belfort … (2011)

To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO). Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension. We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO. At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was 250 μm. The primary outcome for the open-label extension was safety; BCVA was also evaluated. At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a ≥ 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A ≥ 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively. Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression. Proprietary or commercial disclosure may be found after the references. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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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.

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The epidemiology of retinal vein occlusion: the Beaver Dam Eye Study.

Barbara Klein, S Meuer, S Moss … (1999)

To describe the prevalence and the 5-year incidence of retinal central and branch vein occlusion and associated risk factors. The Beaver Dam Eye Study (n = 4,926) is a population-based study in which retinal vein occlusions were detected at baseline (1988-1990) and at a 5-year follow-up examination (1993-1995) by grading of 30 degrees color fundus photographs. The prevalence and 5-year incidence of retinal branch vein occlusion were each 0.6%. The prevalence of retinal central vein occlusion was 0.1%, and the 5-year incidence was 0.2%. While adjusting for age, the prevalence of branch vein occlusion was associated with hypertension (odds ratio [OR] 5.42, 95% confidence interval [CI] 2.18, 13.47), diabetes mellitus (OR 2.43, 95% CI 1.04, 5.70), pulse pressure (OR 1.24 for 10 mm Hg, 95% CI 1.03, 1.48), ocular perfusion pressure (OR 2.09 for 10 mm Hg, 95% CI 1.45, 3.01), arteriovenous nicking (OR 16.75, 95% CI 7.33, 38.24), and focal arteriolar narrowing (OR 22.86, 95% CI 8.43, 62.03). The age-adjusted incidence of retinal branch vein occlusion was associated with current smoking (OR 4.43 95%, CI 1.53, 12.84) compared with nonsmokers and to focal arteriolar narrowing (OR 5.24, 95% CI 1.97, 13.94) at baseline. While controlling for age, the incidence of branch vein occlusion was not associated with serum lipid levels, body mass index, white blood cell count, alcohol consumption, aspirin use, glaucoma, intraocular pressure, or ocular hypertension. Retinal vein occlusion is infrequent in the population. These data suggest a strong association between retinal branch vein occlusion and retinal arteriolar changes. Data from larger populations are needed to further assess associations between risk factors and the incidence of retinal vein occlusions.

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Author and article information

Journal

Journal ID (nlm-ta): Medicine (Baltimore)

Journal ID (iso-abbrev): Medicine (Baltimore)

Journal ID (publisher-id): MEDI

Title: Medicine

Publisher: Wolters Kluwer Health

ISSN (Print): 0025-7974

ISSN (Electronic): 1536-5964

Publication date Collection: May 2019

Publication date (Electronic): 31 May 2019

Volume: 98

Issue: 22

Electronic Location Identifier: e15798

Affiliations

[a ]Department of Ophthalmology, Renmin Hospital of Wuhan University, Wuhan Hubei

[b ]Affiliated Eye Hospital of Nanchang University, Nanchang Jiangxi, China.

Author notes

[∗ ]Correspondence: Yiqiao Xing, Department of Ophthalmology, Renmin Hospital of Wuhan University, 238 Jiefang Road, Wuhan, Hubei 430060, China (e-mail: whdxyyk@ 123456126.com ).

Article

Publisher ID: MD-D-19-00852 Accession ID: 15798

DOI: 10.1097/MD.0000000000015798

PMC ID: 6709010

PubMed ID: 31145307

SO-VID: 08d20f3d-0558-43f8-8552-c5261e35b2c4

License:

This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

History

Date received : 31 January 2019

Date revision received : 27 April 2019

Date accepted : 2 May 2019

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Keywords: anti-vegf,branch retinal vein occlusion,dexamethasone intravitreal implant,macular edema,meta-analysis

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Keywords: anti-vegf, branch retinal vein occlusion, dexamethasone intravitreal implant, macular edema, meta-analysis

Comparison of dexamethasone intravitreal implant with intravitreal anti-VEGF injections for the treatment of macular edema secondary to branch retinal vein occlusion : A meta-analysis

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Most cited references 23

Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results.

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

The epidemiology of retinal vein occlusion: the Beaver Dam Eye Study.

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