Study on half-dose Photodynamic therapy versus Eplerenone in chronic CenTRAl serous chorioretinopathy (SPECTRA trial)

Phase 4

Completed

Conditions: chronic central serous chorioretinopathy
10047060

Registration Number: NL-OMON50407

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 107

Inclusion Criteria

This study will enroll subjects with chronic central serous chorioretinopathy
(cCSC) with active leakage of fluid to under the retina as evidenced on optical
coherence tomography (OCT) scanning and further supported by findings on
fluorescein angiography (FA) and indocyanine green angiography (ICGA), in at
least 1 eye, who visit the outpatient clinic of the Department of Ophthalmology
of the Radboud University Medical Center, the Academic Medical Center
Amsterdam, or the Leiden University Medical Center. If both eyes are eligible,
then the eye with the longer duration of disease will be used as the study eye,
except in cases where the disease is present for more then 18 months. In the
latter case, which is an exclusion criterion, the other eye will be eligible
for inclusion if the disease is active for less then 18 months in that eye. If
the non-study eye also has active disease, the choice to treat and the type of
treatment in this eye may be chosen freely at the discretion of the responsible
ophthalmologist.
Before enrolment, each subject must meet all of the following inclusion
criteria and none of the exclusion criteria, and agree to comply with the study
requirements including completion of all of the study visits.In order to be
eligible to participate in this study, a subject must meet all of the following
criteria:
- Age of >= 18 years of age and able to give written informed consent;
- Active cCSC;
- Subjective visual loss for more then 6 weeks, interpreted as onset of active
disease;
- Foveal subretina fluid on OCT, at Baseline Examination;
- >=1 ill-defined hyperfluorescent leakage areas on FA with retinal pigment
epithelial window defect(s) that are compatible with cCSC;
- Hyperfluorescent areas on ICGA.Bá*CBC

Exclusion Criteria

A potential subject who meets any of the following criteria for the study eye
will be excluded from participation in this study:
- Any previous treatments for active CSC;
- Previous prescription of mineralocorticoid receptor antagonists, for cCSC or
for other diseases;
- Current treatment with corticosteroids (topical or systemic), corticosteroid
use within 3 months before possible start of trial treatment, or anticipated
start of corticosteroid treatment within the first 2 years from the start of
the trial period;
- Evidence of another diagnosis that can explain serous SRF or visual loss;
- BCVA < 20/200 (Snellen equivalent);
- Profound chorioretinal atrophy in central macular area on ophthalmoscopy and
OCT;
- Myopia > 6D;
- Visual loss and/or serous detachment on OCT < 6 weeks;
- Continuous and/or progressive visual loss > 18 months or serous detachment on
OCT > 18 months;
- No hyperfluorescence on ICGA;
- Intraretinal edema on OCT;
- (relative) Contraindications for FA or ICGA;
- (relative) Contraindications for PDT treatment (pregnancy, porphyria,
severely disturbed liver function). Pregnancy will not be routinely tested in
female patients, but the possibility of pregnancy will be discussed during
screening;
- (relative) Known contraindications for initiation of eplerenone treatment
(hyperkalemia, abnormal renal clearance, severe hepatic insufficiency
(Child-Pugh C), type 2 diabetes mellitus with microalbuminuria, concomitant use
of potassium supplements, potassium-sparing diuretics, strong CYP3A4
inhibitors, or the combination of an ACE-inhibitor and an angiotensin receptor
blocking agent). Pregnancy will not be routinely tested in female patients, but
the possibility of pregnancy will be discussed during screening;
- Soft drusen in treated eye or fellow eye, signs of choroidal
neovascularization on ophthalmoscopy and/or FA/ICGA of the study eye. The
previous prescription of oral medication (for example, acetazolamide) for cCSC,
except the prescription of previous mineralocorticoid receptor antagonists, is
not an exclusion criterion for this study.BKKá*J