Comparing half-dose photodynamic therapy with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy the PLACE trial: study protocol for a randomized controlled trialReport as inadecuate




Comparing half-dose photodynamic therapy with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy the PLACE trial: study protocol for a randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 16:419

First Online: 21 September 2015Received: 01 April 2015Accepted: 03 September 2015DOI: 10.1186-s13063-015-0939-z

Cite this article as: Breukink, M.B., Downes, S.M., Querques, G. et al. Trials 2015 16: 419. doi:10.1186-s13063-015-0939-z

Abstract

BackgroundChronic central serous chorioretinopathy cCSC is an eye disease characterized by an accumulation of serous fluid under the retina. It is postulated that this fluid accumulation results from hyperpermeability and swelling of the choroid, the underlying vascular tissue of the eye, causing a dysfunction of the retinal pigment epithelium. This fluid accumulation causes neuroretinal detachment. A prolonged neuroretinal detachment in the macula can lead to permanent vision loss. Therefore, treatment is aimed primarily at achieving resolution of subretinal fluid, preferably within the first 4 months after diagnosis of the disease. A broad spectrum of treatment modalities has been investigated in cCSC, but no consensus exists on the optimal treatment of cCSC. Currently, photodynamic therapy PDT and high-density subthreshold micropulse laser treatment HSML are among the most frequently cited treatments in obtaining successful neuroretinal reattachment.

Methods-DesignThis is a randomized, controlled, open-label, multicenter trial comparing the efficacy of half-dose PDT to HSML in treating patients with cCSC. A total of 156 patients will be recruited, 78 patients in each treatment arm, with a maximum follow-up duration of 8 months after the first treatment. A complete ophthalmological examination with vision-related quality of life NEI VFQ-25 and stress questionnaires, will be performed at baseline, 6 to 8 weeks after the first treatment, 6 to 8 weeks after a second treatment if necessary, and at the final follow-up visit at 7 to 8 months after the first treatment. Treatment visits will be scheduled within 3 weeks after the baseline visit, and within 3 weeks after the first control visit, if a second treatment is required.

DiscussionBoth half-dose PDT and HSML may be effective treatments in cCSC, but because of the lack of prospective randomized controlled trials, which treatment should be the first choice remains unclear. The aim of this study is to compare the efficacy of half-dose PDT to HSML. The primary endpoint to evaluate efficacy will be a complete absence of subretinal fluid on optical coherence tomography after treatment. Secondary functional endpoints include change in Early Treatment Diabetic Retinopathy Study ETDRS best-corrected visual acuity, retinal sensitivity on microperimetry, and NEI VFQ-25 questionnaire of visual functioning.

Registration number Institutional Review Board CMO Arnhem-Nijmegen, the Netherlands: 2013-203 NL nr.: 41266.091.13

Trial registrationClinicalTrials.gov identifier: NCT01797861. Date of registration: 21 February 2013.

Keywordschronic central serous chorioretinopathy half-dose photodynamic therapy high-density subthreshold micropulse laser prospective randomized controlled multicenter trial verteporfin AbbreviationsAEadverse event

ARadverse reaction

BCVAbest-corrected visual acuity

CIChief Investigator

CRCCentral Reading Center

CRFcase report form

CSCcentral serous chorioretinopathy

cCSCchronic central serous chorioretinopathy

DMCdata monitoring committee

ETDRSEarly Treatment of Diabetic Retinopathy Study

GPGeneral Practitioner

HSMLhigh-density subthreshold micropulse laser

ICGindocyanine green

ICH-GCPInternational Convention of Helsinki - Good Clinical Practice

NEI-VFQ-25National Eye Institute Visual Function Questionnaire 25

OCToptical coherence tomography

PDTphotodynamic therapy

PIPrincipal Investigator

RandDResearch and Development

RECresearch ethics committees

RPEretinal pigment epithelium

SAEserious adverse event

SARserious adverse reaction

SOPstandard operating procedure

SRFsubretinal fluid

SUSARsuspected unexpected serious adverse events

TMFtrial master file

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Author: Myrte B. Breukink - Susan M. Downes - Giuseppe Querques - Elon H. C. van Dijk - Anneke I. den Hollander - Rocio Blanco-

Source: https://link.springer.com/







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