Evidence map›Paper›PMID 32041720›Full record

Trial reportThe British journal of ophthalmology2020

Prospective exploratory study to assess the safety and efficacy of aflibercept in cystoid macular oedema associated with retinitis pigmentosa.

Stacey A Strong, Tunde Peto, Catey Bunce, Wen Xing, Michalis Georgiou, Simona Degli Esposti, Angelos Kalitzeos, Andrew Webster, Michel Michaelides

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIControlled Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02661711 (Prospective Non-randomised Exploratory Study to Assess the Safety and Efficacy of Aflibercept), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 10% 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.

NCT02661711 phase2completednot on this map

Prospective Non-randomised Exploratory Study to Assess the Safety and Efficacy of Aflibercept (Eylea) in Cystoid Macular Oedema (CMO) Associated With Retinitis Pigmentosa (RP)

TypeinterventionalSponsorMoorfields Eye Hospital NHS Foundation TrustRan2016 to 2017Enrolled30ConditionsMacular Oedema, Retinitis PigmentosaArmsAflibercept
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Oral minocycline for the treatment of retinitis pigmentosa-associated cystoid macular edema: results of a phase I/II clinical trial.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2023
    Trial
  3. Review
  4. Article
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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

9 authors at 4 institutions in 4 countries.

Stacey A StrongUCL Institute of Ophthalmology, University College London, London, UK.ORCID 0000-0002-7805-2412
Tunde PetoMoorfields Eye Hospital, London, UK.
Catey BuncePrimary Care and Public Health Sciences, Kings College London, London, UK.ORCID 0000-0002-0935-3713
Wen XingMoorfields Eye Hospital, London, UK.
Michalis GeorgiouUCL Institute of Ophthalmology, University College London, London, UK.ORCID 0000-0001-6397-8071
Simona Degli EspostiMoorfields Eye Hospital, London, UK.
Angelos KalitzeosUCL Institute of Ophthalmology, University College London, London, UK.
Andrew WebsterUCL Institute of Ophthalmology, University College London, London, UK.
Michel MichaelidesUCL Institute of Ophthalmology, University College London, London, UK michel.michaelides@ucl.ac.uk.
Institute of Ophthalmology · MXMoorfields Eye Hospital · GBKing's College - North Carolina · USQueen's University Belfast · GB

Funding

Wellcome TrustWellcome Trust 099173/Z/12/Z
6 · The paper itself

Abstract

aimsTo report the safety and efficacy of intravitreal aflibercept (Eylea) (ivA) for retinitis pigmentosa-associated cystoid macular oedema (RP-CMO) at 12 months via mean central macular thickness (CMT) and reported adverse events.

methodsA prospective, exploratory, phase II, non-randomised, single-centre, open-label, 1-arm clinical trial involving 30 eyes of 30 patients. Serial ivA was given via loading dose (three injections) followed by treat and extend protocol over 12 months.

resultsTwenty-nine out of 30 (96.7%) patients completed 12 months of follow-up. A total of four to 11 injections per patient were given over the 12 month study. No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall. Eleven out of 29 (37.9%) participants were considered as 'responders', demonstrating at least an 11% reduction of CMT at 12 months on spectral domain optical coherence tomography compared with baseline. A reduction of CMT by mean (SD) 28.1% (12.9 %) was observed in responders at 12 months, however, no statistically significant corresponding improvement in best corrected VA was seen. Baseline characteristics were similar between responder and non-responder groups. No clinically significant adverse events were deemed secondary to ivA.

conclusionThis first prospective exploratory study demonstrates both the safety and acceptability of serial ivA in patients with RP-CMO, effective at reducing CMT in 37.9% of patients. All patients demonstrating anatomical response did so after their first injection. Longer duration of CMO did not negatively affect response to anti-VEGF. Further study in a larger cohort of patients with shorter CMO duration would be valuable to better establish the utility of VEGF blockade in RP-CMO. TRIAL REGISTRATION NUMBERS: EudraCT (2015-003723-65); ClinicalTrials.gov (NCT02661711).

Indexed as

AdultAngiogenesis InhibitorsFemaleFollow-Up StudiesHumansIntravitreal InjectionsMacular EdemaMaleMiddle AgedProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsRetinaRetinitis PigmentosaTomography, Optical CoherenceTreatment OutcomeafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AVEGFA protein, humanmacularetina

Identifiers

PMID32041720
PMCPMC7577098
OpenAlexW3004846985

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.