Evidence map›Paper›PMID 25885285›Full record

Trial reportBMC ophthalmology2015

Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study.

Michael A Singer, Antonio Capone, Pravin U Dugel, Richard F Dreyer, David G Dodwell, Daniel B Roth, Rui Shi, John G Walt, Lanita C Scott, David A Hollander and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01411696 (Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 6% of its field
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.

NCT01411696 completednot on this map

Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)

TypeobservationalSponsorAllerganRan2011 to 2012Enrolled289ConditionsRetinal Vein Occlusion, Macular EdemaArmsdexamethasone intravitreal implant 0.7 mg
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. 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.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2018
    Trial
  3. Dexamethasone intravitreal implant in retinal vein occlusion: real-life data from a prospective, multicenter clinical trial.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2017
    Trial
  4. Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2016
    Trial
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Reply to a letter to the editor: Dexamethasone intravitreal implant in retinal vein occlusion: real-life data from a prospective, multicenter clinical trial.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2017
    Article
  12. Article
  13. Retinal vein occlusion and the use of a dexamethasone intravitreal implant (Ozurdex®) in its treatment.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2016
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 2 countries.

Michael A SingerMedical Center Ophthalmology Associates, 9157 Huebner Road, San Antonio, TX, 78240, USA. msinger11@mac.com.
Antonio CaponeAssociated Retinal Consultants, Novi, MI, USA. acaponejr@yahoo.com.
Pravin U DugelRetinal Consultants of Arizona, Phoenix, AZ, USA. pdugel@gmail.com.
Richard F DreyerRetina Northwest PC, Portland, OR, USA. rdreyer@msn.com.
David G DodwellIllinois Retina Center, Springfield, IL, USA. daviddodwell@comcast.net.
Daniel B RothRetina-Vitreous Center, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA. rothretina@gmail.com.
Rui ShiAllergan, Inc., Irvine, CA, USA. Shi_Rui@Allergan.com.
John G WaltAllergan, Inc., Irvine, CA, USA. johngwalt@gmail.com.
Lanita C ScottAllergan, Inc., Irvine, CA, USA. Scott_Lanita@Allergan.com.
David A HollanderAllergan, Inc., Irvine, CA, USA. Hollander_David@Allergan.com.
SHASTA Study Group
Allergan (Ireland) · IEJohnson University · USMedical Center Ophthalmology Associates · USRetinal Consultants of Arizona · USEducation Northwest · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDexamethasone intravitreal implant (DEX implant) is a sustained-release biodegradable implant approved for treatment of macular edema associated with retinal vein occlusion (RVO). The safety and efficacy of treatment of RVO-associated macular edema with sequential DEX implants in clinical practice was evaluated in patients who received DEX implant as monotherapy compared with patients who received DEX implant in combination with other RVO treatments.

methodsA multicenter, retrospective, open-label chart review study (one study eye/patient) evaluated use of DEX implant and outcomes in 289 patients with branch or central RVO who received at least 2 DEX implant treatments in the study eye. Data were collected from the time of the first implant (baseline) to 3-6 months after the last implant. Subgroup analysis evaluated outcomes in patients receiving only DEX implant during the study versus patients receiving DEX implant plus adjunctive RVO treatments. Endpoints included best-corrected visual acuity (BCVA) and central retinal thickness (CRT) change from baseline.

resultsDEX implant was used as monotherapy in 84 (29.1%) patients and in combination with other therapy in 205 (70.9%) patients. Mean number of DEX implant treatments received was 3.1 in the monotherapy group and 3.3 in the combination therapy group (P = 0.344). Mean time between implants was longer in the combination therapy group (177 vs. 151 days, P < 0.001). Mean change from baseline BCVA after the first through sixth DEX implants ranged from +0.6 to +3.4 lines in the monotherapy group and +1.3 to +2.8 lines in the combination therapy group. Mean decrease from baseline CRT ranged from 165 to 230 μm in the monotherapy group and 136 to 175 μm in the combination therapy group. Increased intraocular pressure was more common in the combination therapy group.

conclusionsTreatment of RVO-associated macular edema with at least 2 sequential DEX implants was safe and effective both when used alone and when combined with other RVO treatments. Improvements in BCVA and CRT were generally similar in the monotherapy and combined therapy groups.

trial registrationClinicalTrials.gov NCT01411696 .

Indexed as

AgedDexamethasoneDose-Response Relationship, DrugDrug ImplantsFemaleFollow-Up StudiesGlucocorticoidsHumansIntravitreal InjectionsMacular EdemaMaleRetinal Vein OcclusionRetrospective StudiesTime FactorsTomography, Optical CoherenceVisual AcuityDexamethasoneDrug ImplantsGlucocorticoids

Identifiers

PMID25885285
PMCPMC4391088
OpenAlexW2012002766

What OpenQuestion holds

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LicenceCC BY
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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.