Research with human participants

Overview of medical research in the Netherlands

Early treatment of central serous retinopathy by photodynamic therapy. A randomized controlled trial.

Published:
Last updated:

To determine the outcome in CSR patients comparing treatment with PDT versus observation.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Retina, choroid and vitreous haemorrhages and vascular disorders
Study type
Interventional

ID

NL-OMON45189

Source

ToetsingOnline

Brief title

CSR & PDT

Condition

  • Retina, choroid and vitreous haemorrhages and vascular disorders

Synonym

central serous retinopathy

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Stichting Wetenschappelijk Onderzoek Oogziekenhuis (SWOO)

Intervention

Keyword :
central serous retinopathy, photodynamic therapy, poor prognostic factors

Outcome measures

Primary outcome

Visual acuity at 1 year.

Secondary outcome

Metamorphopsia, color vision, recurrence, presence of persistent subretinal

fluid on OCT, lesion size on autofluorescence imaging.

Background summary

There is no agreement concerning the early treatment of central serous
retinopathy (CSR). In literature, clinical case series using PDT show favorable
results. No randomized controlled trials however exist. In the last trial *Long
term follow-up of central serous retinopathy. An observational case
series* (protocol OZR-2007-02, MEC-2007-105) prognostic factors available at
first presentation could be identified. As a result of these findings, this
protocol proposes a randomized controlled trial in patients with CSR with poor
prognostic factors. Patients will be randomized between an observational and an
early PDT treatment arm. In the observational arm, patients with persistent
lesions at 3 months will be treated with PDT in agreement with current standard
of care.

Study objective

To determine the outcome in CSR patients comparing treatment with PDT versus
observation.

Study design

Prospective randomized controlled trial.

Intervention

PDT versus observation.

Study burden and risks

Risks are considered to be small. Study-related visits and/or time:
extra visits (3 &4) at 3 & 6 months; extra time 4X30 minutes (visits 1, 3, 4
and 5).

Public
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL
Scientific
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Age > 18 years.
Informed consent.
Poor prognositic acute CSR.

Exclusion criteria

History of CSR in either eye.
Allergy to fluorescein dyes.
Allergy to visudyne.
Opaque ocular media, impairing regular fundus imaging
Other ocular disorder possibly reducing visual acuity

Design

Study phase :
3
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
60
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Visudyne
Generic name :
verteporfine
Registration
:
Yes - NL outside intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2009-017959-98-NL
CCMO NL30929.078.09