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


- candidate number7879
- NTR NumberNTR2261
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2010
- Secondary IDs2009-26 / 2007-105 ; Oogziekenhuis Rotterdam / MEC
- Public TitleEarly treatment of central serous retinopathy by photodynamic therapy. A randomized controlled trial.
- Scientific TitleEarly treatment of central serous retinopathy by photodynamic therapy. A randomized controlled trial.
- ACRONYMCSR & PDT
- hypothesisVisual outcome in CSR patients is superior when treated by Photodynamic Therapy (PDT) compared to observation.
- Healt Condition(s) or Problem(s) studiedCentral serous retinopathy
- Inclusion criteria1. Age > 18 years;
2. Informed consent;
3. Poor prognositic acute CSR.
- Exclusion criteria1. History of CSR in either eye;
2. Allergy to fluorescein dyes;
3. Allergy to visudyne;
4. Opaque ocular media, impairing regular fundus imaging;
5. Other ocular disorder possibly reducing visual acuity.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2010
- planned closingdate31-mrt-2012
- Target number of participants60
- InterventionsPhotodynamic therapy (PDT) versus observation. In the observational arm, patients with persistent lesions at 3 months will be treated with PDT in agreement with current standard of care.
PDT: Visudyne is applied intravenous. After several minutes, the visudyne has reached the retina. When beaming the retina, a photochemical reaction takes place which destroys the neovascularisation.
- Primary outcomeVisual acuity at 1 year (ETDRS letter cart).
- Secondary outcome1. Metamorphopsia (Amsier cart);
2. Color vision (Hardy Rand Ritter colortest);
3. Recurrence (Optical Coherence Tomographt);
4. Presence of persistent subretinal fluid on OCT;
5. Lesion size on autofluorescence imaging (OCT).
- TimepointsBaseline, 3 months, 6 months.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES T. Missotten
- CONTACT for SCIENTIFIC QUERIES T. Missotten
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
- PublicationsN/A
- Brief summaryRationale:
There is no agreement concerning the early treatment of central serous retinopathy (CSR). In literature, clinical case series using photodynamic therapy (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.

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

Study design:
Prospective randomized controlled trial.

Study population:
Patients presenting with CSR (N=50) with poor prognostic factors.

Main study endpoint:
Visual acuity at 1 year.
Secondary study endpoints: Metamorphopsia, color vision, recurrence, presence of persistent subretinal fluid on OCT, lesion size on autofluorescence imaging.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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).
- Main changes (audit trail)
- RECORD26-mrt-2010 - 22-okt-2017


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