Evidence map›Paper›PMID 34266844›Full record

Trial reportBMJ open2021

Multicentre, randomised clinical trial comparing intravitreal aflibercept monotherapy versus aflibercept combined with reduced-fluence photodynamic therapy (RF-PDT) for the treatment of polypoidal choroidal vasculopathy.

Chinmayi Himanshuroy Vyas, Chui Ming Gemmy Cheung, Colin Tan, Caroline Chee, Kelly Wong, Janice Marie N Jordan-Yu, Tien Yin Wong, Anna Tan, Beau Fenner, Shaun Sim and 1 more

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

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03941587 (A Multi-center Randomized Clinical Trial Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT for the Treatment of Polypoidal Choroidal Vasculopathy), which is not on this 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
0.9field-weighted citation impact, top 27% 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.

NCT03941587 nacompletednot on this map

A Multi-center Randomized Clinical Trial Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT for the Treatment of Polypoidal Choroidal Vasculopathy

TypeinterventionalSponsorSingapore National Eye CentreRan2021 to 2024Enrolled60ConditionsPolypoidal Choroidal VasculopathyArmsAflibercept + reduced fluence photodynamic therapy (RF-PDT), Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT)
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  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

11 authors at 5 institutions in 1 country.

Chinmayi Himanshuroy VyasSingapore Eye Research Institute, Singapore.
Chui Ming Gemmy CheungSingapore Eye Research Institute, Singapore.ORCID 0000-0003-3358-3516
Colin TanDepartment of Ophthalmology, Tan Tock Seng Hospital, Singapore.
Caroline CheeDepartment of Ophthalmology, National University Hospital, Singapore.
Kelly WongSingapore Eye Research Institute, Singapore.
Janice Marie N Jordan-YuSingapore Eye Research Institute, Singapore.
Tien Yin WongSingapore Eye Research Institute, Singapore.ORCID 0000-0002-8448-1264
Anna TanSingapore Eye Research Institute, Singapore.
Beau FennerMedical Retina, Singapore National Eye Centre, Singapore.
Shaun SimMedical Retina, Singapore National Eye Centre, Singapore.
Kelvin Yi Chong TeoSingapore Eye Research Institute, Singapore kelvin.teo.y.c@singhealth.com.sg.ORCID 0000-0002-6197-8681
Singapore National Eye Center · SGSingapore Eye Research Institute · SGNational University Hospital · SGSingHealth · SGTan Tock Seng Hospital · SG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the efficacy and safety of intravitreal aflibercept (IVA) monotherapy versus aflibercept combined with reduced-fluence photodynamic therapy (RF-PDT) (IVA+RF-PDT) for the treatment of polypoidal choroidal vasculopathy (PCV). METHODS AND ANALYSIS: Multicentred, double-masked, randomised controlled trial to compare the two treatment modalities. The primary outcome of the study is to compare the 52-week visual outcome of IVA versus IVA+RF PDT. One hundred and sixty treatment-naïve patients with macular PCV confirmed on indocyanine green angiography will be recruited from three centres in Singapore. Eligible patients will be randomised (1:1 ratio) into one of the following groups: IVA monotherapy group-aflibercept monotherapy with sham photodynamic therapy (n=80); combination group-aflibercept with RF-PDT (n=80). Following baseline visit, all patients will be monitored at 4 weekly intervals during which disease activity will be assessed based on best-corrected visual acuity (BCVA), ophthalmic examination findings, optical coherence tomography (OCT) and angiography where indicated. Eyes that meet protocol-specified retreatment criteria will receive IVA and sham/RF-PDT according to their randomisation group. Primary endpoint will be assessed as change in BCVA at week 52 from baseline. Secondary endpoints will include anatomical changes based on OCT and dye angiography as well as safety assessment. Additionally, we will be collecting optical coherence tomography angiography data prospectively for exploratory analysis. ETHICS AND DISSEMINATION: This study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the ICH E6 guidelines of Good Clinical Practice and the applicable regulatory requirements. Approval from the SingHealth Centralised Institutional Review Board has been sought prior to commencement of the study. TRIAL REGISTRATION NUMBER: NCT03941587.

Indexed as

PhotochemotherapyPolypsAngiogenesis InhibitorsChoroidFluorescein AngiographyFollow-Up StudiesHumansIntravitreal InjectionsPhotosensitizing AgentsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsSingaporeTomography, Optical CoherenceTreatment OutcomeVisual AcuityafliberceptAngiogenesis InhibitorsPhotosensitizing AgentsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteinsclinical trialsmedical ophthalmologymedical retina

Identifiers

PMID34266844
PMCPMC8286776
OpenAlexW3178769016

What OpenQuestion holds

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LicenceCC BY-NC
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.