Evidence map›Paper›PMID 35983162›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2022

A Real-World, Multicenter, 6-Month Prospective Study in Greece of the Effectiveness and Safety of Ranibizumab in Patients with Age-Related Macular Degeneration Who Have Inadequately Responded to Aflibercept: The "ELEVATE" Study.

Alexandros Rouvas, Ioannis Datseris, Sofia Androudi, Miltiadis Tsilimbaris, Stamatina A Kabanarou, Nikolaos Pharmakakis, Chryssanthi Koutsandrea, Alexander Charonis, Olga Kousidou, Georgia Pantelopoulou

Open access · goldAbstract read
In one paragraph

Article in Clinical ophthalmology (Auckland, N.Z.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 36% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. 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

10 authors at 7 institutions in 1 country.

Alexandros Rouvas2nd Department of Ophthalmology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Ioannis DatserisOMMA Ophthalmological Institute of Athens, Athens, Greece.
Sofia AndroudiOphthalmology Clinic, University of Thessaly, Larissa, Greece.
Miltiadis TsilimbarisOphthalmological Clinic, University of Crete Medical School, Heraklion, Greece.
Stamatina A KabanarouDepartment of Ophthalmology, General Hospital of Athens 'korgialenio-Benakio', Athens, Greece.ORCID 0000-0002-4225-7619
Nikolaos PharmakakisDepartment of Ophthalmology, University of Patras, Patras, Greece.
Chryssanthi KoutsandreaDepartment of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.
Alexander CharonisRetina Service, Athens Vision Eye Institute, Athens, Greece.
Olga KousidouMedical Department, Novartis (Hellas), Athens, Greece.ORCID 0000-0001-7587-8764
Georgia PantelopoulouMedical Department, Novartis (Hellas), Athens, Greece.ORCID 0000-0001-5523-6406
National and Kapodistrian University of Athens · GRAthens Eye Hospital · GRHellenic Red Cross · GRNeurological Institute of Athens · GRUniversity of Crete · GRUniversity of Patras · GRUniversity of Thessaly · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Real-world evidence on short-term outcomes of ranibizumab in wet age-related macular degeneration (wAMD) following inadequate response to aflibercept is scarce. This study aimed to evaluate the functional and anatomic effects of switching to ranibizumab in cases of wAMD previously treated with aflibercept with inadequate response. Patients and Methods: Prospective, observational study performed in eight ophthalmology hospital/private clinics in Greece, enrolling consented patients with active wAMD, ≥50 years-old, who had initiated ranibizumab ≥28 days and <2 months after their last aflibercept injection. Data were collected at enrollment, and at 1, 3 and 6 months post-treatment onset (post-baseline). Results: Between September-2015 and November-2017, 103 eligible patients (56.3% females; mean age: 74.8±8.6 years) were consecutively enrolled. The age at AMD diagnosis in the study eye was 71.3±8.8 years. Aflibercept (median of 5 injections received over 11.3 months) had been discontinued for anatomical (in 69.9%) and/or functional (38.8%) reasons. At baseline (median: 24.3 months after wAMD diagnosis), choroidal neovascularization was occult in 69.1% of evaluable study eyes; 60.2% of the study eyes had pigment epithelial detachment (PED); 42.7% cysts; 21.4% fibrosis; 66.0% subretinal, and 59.2% intraretinal fluid. At 6 months post-baseline: a median of 3 ranibizumab injections (range: 1-6) had been received; the best-corrected visual acuity (BCVA)≥0 letter gain rate was 81.8%; the BCVA ≥15 letter gain rate was 17.0%; BCVA gain was 3.2 letters [mean increase: 3.2±10.0 letters; median: 0.0; p = 0.002]; PED greatest basal diameter (GBD; median: 1470.5 μm) also decreased (median decrease: 114.0 μm; p = 0.019). Baseline central retinal thickness (CRT; median: 312.0 μm) remained unchanged. One patient permanently discontinued ranibizumab due to adverse event occurrence, assessed as not causally related to ranibizumab. There were no ranibizumab-related adverse reactions. Conclusion: Six-month treatment with ranibizumab in aflibercept inadequate responders led to visual acuity and PED GBD improvements, with no statistically significant CRT change.

Indexed as

best corrected visual acuitycentral retinal thicknesspigment epithelial detachment

Identifiers

PMID35983162
PMCPMC9380822
OpenAlexW4290999894

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.