Evidence map›Paper›PMID 29119239›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2018

Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study.

Xiaoxin Li, Ningli Wang, Xiaoling Liang, Gezhi Xu, Xiao-Yan Li, Jenny Jiao, Jean Lou, Yehia Hashad, China Ozurdex in RVO Study Group

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01660802 (Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion), which is not on this map. Cited by 36 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01660802 phase3completednot on this map

Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

TypeinterventionalSponsorAllerganRan2012 to 2014Enrolled262ConditionsMacular EdemaArms700 μg Dexamethasone, Sham
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  14. Incidence and treatment approach of intraocular pressure elevation after various types of local steroids for retinal diseases.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2023
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  16. Evaluating the One-Year Efficacy of Combined Anti-VEGF and Dexamethasone Implant Treatment for Macular Edema in Retinal Vein Occlusions.Medical science monitor : international medical journal of experimental and clinical research · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Xiaoxin LiPeople's Eye Center, Peking University People's Hospital, Xizhimen South Street 11, Beijing, 100044, China. drlixiaoxin@163.com.
Ningli WangBeijing Tongren Eye Center, Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Xiaoling LiangState Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangzhou, China.
Gezhi XuDepartment of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai, China.
Xiao-Yan LiAllergan plc, Irvine, CA, USA.
Jenny JiaoAllergan plc, Irvine, CA, USA.
Jean LouAllergan plc, Irvine, CA, USA.
Yehia HashadAllergan plc, Irvine, CA, USA.
China Ozurdex in RVO Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this study was to evaluate the safety and efficacy of dexamethasone intravitreal implant 0.7 mg (DEX) for treatment of macular edema associated with retinal vein occlusion (RVO).

methodsThis study was a six-month, randomized, double-masked, sham-controlled, multicenter, phase 3 clinical trial with a 2-month open-label study extension. Patients with branch or central RVO received DEX (n = 129) or sham procedure (n = 130) in the study eye at baseline; all patients who met re-treatment criteria received DEX at month 6. Efficacy measures included Early Treatment Diabetic Retinopathy Study (ETDRS), best-corrected visual acuity (BCVA), and central retinal thickness (CRT) on optical coherence tomography.

resultsTime to ≥15-letter BCVA improvement from baseline during the first 6 months (primary endpoint) was earlier with DEX than sham (p < 0.001). At month 2 (peak effect), the percentage of patients with ≥15-letter BCVA improvement from baseline was DEX: 35%, sham: 12%; mean BCVA change from baseline was DEX: +10.6 letters, sham: +1.7 letters; and mean CRT change from baseline was DEX: -407 μm, sham: -62 μm (all p < 0.001). Outcomes were better with DEX than sham in both branch and central RVO. The most common treatment-emergent adverse event was increased intraocular pressure (IOP). Increases in IOP generally were controlled with topical medication. Mean IOP normalized by month 4, and no patient required incisional glaucoma surgery.

conclusionsDEX had a favorable safety profile and provided clinically significant benefit in a Chinese patient population with RVO. Visual and anatomic outcomes were improved with DEX relative to sham for 3-4 months after a single implant.

Indexed as

Visual AcuityAdultAgedChinaDexamethasoneDouble-Blind MethodDrug ImplantsFemaleFollow-Up StudiesGlucocorticoidsHumansIncidenceIntraocular PressureIntravitreal InjectionsMacular EdemaMaleDexamethasoneDrug ImplantsGlucocorticoidsCorticosteroidDrug delivery systemIntravitreal injectionMacular edemaRandomized controlled trialRetinal vein occlusion

Identifiers

PMID29119239
PMCPMC5748421

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.