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

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).

Visual outcome in CSR patients is superior when treated by Photodynamic Therapy (PDT) compared to observation.

Baseline, 3 months, 6 months.

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.