No registrations found.
ID
Source
Brief title
Health condition
Central serous retinopathy.
Sponsors and support
Schiedamse Vest 180
3011 BH Rotterdam
Nederland
Intervention
Outcome measures
Primary outcome
Visual acuity at 1 year (ETDRS letter cart).
Secondary outcome
1. 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).
Background summary
Rationale:
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).
Study objective
Visual outcome in CSR patients is superior when treated by Photodynamic Therapy (PDT) compared to observation.
Study design
Baseline, 3 months, 6 months.
Intervention
Photodynamic 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.
Schiedamsevest 180,
T. Missotten
Rotterdam 3011 BH
The Netherlands
010 401777
t.missotten@oogziekenhuis.nl
Schiedamsevest 180,
T. Missotten
Rotterdam 3011 BH
The Netherlands
010 401777
t.missotten@oogziekenhuis.nl
Inclusion criteria
1. Age > 18 years;
2. Informed consent;
3. Poor prognositic acute CSR.
Exclusion criteria
1. 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.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL2137 |
| NTR-old | NTR2261 |
| Other | Oogziekenhuis Rotterdam / MEC : 2009-26 / 2007-105 ; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
PMID: 32264706