Evidence map›Paper›PMID 35768859›Full record

ArticleBMC ophthalmology2022

Switching to ziv-aflibercept in resistant diabetic macular edema non responsive to ranibizumab injection.

Amin E Nawar, Tamer Wasfy, Heba M Shafik

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC ophthalmology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04290195 (Safety and Efficacy of Ziv Aflibercept in Myopic Choroidal Neovascularisation ,Central Retinal Vein Occlusion and Resistant Diabetic Macular Edema), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 42% 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.

NCT04290195 phase1 / phase2completednot on this map

Safety and Efficacy of Ziv Aflibercept in Myopic Choroidal Neovascularisation ,Central Retinal Vein Occlusion and Resistant Diabetic Macular Edema

TypeinterventionalSponsorAmin El Sayed NawarRan2019 to 2020Enrolled55ConditionsCentral Retinal Vein Occlusion With Macular EdemaArmsZiv-Aflibercept 25 MG/ML [Zaltrap]
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
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

3 authors at 1 institution in 1 country.

Amin E NawarDepartment of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, 31516, Egypt. nawar20012002@gmail.com.
Tamer WasfyDepartment of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, 31516, Egypt.
Heba M ShafikDepartment of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, 31516, Egypt.
Tanta University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDiabetic macular edema (DME) is a leading cause of visual loss in diabetic patients and is managed using multiple anti-vascular endothelial growth factor (VEGF) agents such as bevacizumab, ranibizumab and aflibercept. The present study evaluates effectiveness of intravitreal injection of ziv-aflibercept in resistant diabetic macular edema.

methodsThis is a prospective interventional study that was carried out on 59 eyes of 40 diabetic patients with diabetic macular edema resistant to three prior consecutive ranibizumab injections. On all patients, thorough ophthalmic evaluation including optical coherence tomography was performed. In patients with persistent intraretinal or subretinal fluid, ziv- aflibercept 1.25 mg (0.05 ml) was administered by intravitreal injection monthly during the 6 month study period from June to December 2019.

resultsThe central macular thickness (CMT) decreased significantly from 395.08 ± 129.9 um at baseline to 282.39 ± 95.278, 245.36 ± 79.861 and 201.17 ± 54.042 after 1, 3 and 6 months of treatment respectively (p < 0.001). Best corrected visual acuity (BCVA) in log MAR units was significantly improved from 0.95 ± 0.21 to 0.51 ± 0.23 after 6 months (p = 0.001). After treatment, negative correlations were detected between age, number of injections, duration of DM and level of glycated hemoglobin (HbA1c) and variation of both CMT and BCVA. The only significant predictor for low final CMT after 6 months of injection was the CMT after 3 months of injection (p = 0.001).

conclusionZiv-aflibercept is a highly effective and safe drug in cases of DME resistant to previous ranibizumab injections especially in low-income countries.

trial registrationThis study was retrospectively registered at clinicaltrials.gov (ID: NCT04290195) on 28-2-2020.

Indexed as

Diabetic RetinopathyMacular EdemaReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAngiogenesis InhibitorsDiabetes MellitusDrug SubstitutionHumansIntravitreal InjectionsProspective StudiesRanibizumabTomography, Optical CoherenceVisual AcuityafliberceptAngiogenesis InhibitorsRanibizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsDiabetic macular edemaIntravitreal injectionOptical coherence tomographyZiv-aflibercept

Identifiers

PMID35768859
PMCPMC9241277
OpenAlexW4283759886

What OpenQuestion holds

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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.