Photodynamic therapy versus eplerenone in chronic central serous chorioretinopathy

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004119-11-NL

Enrollment

Unknown

Registered

2016-11-09

Start date

2016-12-19

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic central serous chorioretinopathy MedDRA version: 19.0 Level: PT Classification code 10063118 Term: Chorioretinopathy System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: eplerenone Product Name: eplerenone Product Code: SPECT Pharmaceutical Form: Film-coated tablet INN or Proposed INN: eplerenone CAS Number: 107724-20-9 Current Sponsor code: SPECT Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: This study will enroll subjects with cCSC with active leakage of fluid to under the retina as evidenced on OCT scanning and further supported by findings on FA and 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 > 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 6 weeks, interpreted as onset of active disease; - Foveal SRF on OCT, at Baseline Examination; - =1 ill-defined hyperfluorescent leakage areas on FA with RPE window defect(s) that are compatible with cCSC; - Hyperfluorescent areas on ICGA. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

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 6D; - Visual loss and/or serous detachment on OCT 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether half-dose PDT treatment leads to a higher percentage of cCSC patients with SRF on OCT at baseline, achieving an absence of this SRF on OCT as compared to eplerenone treatment.;Secondary Objective: To investigate the clinical outcome comparing half-dose PDT treatment with eplerenone treatment in patients with SRF due to active leakage in cCSC, based on evaluation of best-corrected visual acuity (BCVA), retinal sensitivity on microperimetry, and subjective scores on the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).;Primary end point(s): The primary endpoint of this study is to assess if there is a difference between half-dose PDT and eplerenone treatment in patients with cCSC, in terms of complete resolution of SRF on OCT. The assessment of this efficacy will be based on the anatomical effect on OCT: absence of SRF versus persistence of SRF, at 3 months after the initiation of treatment. ;Timepoint(s) of evaluation of this end point: At 3 months after the initiation of treatment	—

Measure

Time frame

Main Objective: To investigate whether half-dose PDT treatment leads to a higher percentage of cCSC patients with SRF on OCT at baseline, achieving an absence of this SRF on OCT as compared to eplerenone treatment.;Secondary Objective: To investigate the clinical outcome comparing half-dose PDT treatment with eplerenone treatment in patients with SRF due to active leakage in cCSC, based on evaluation of best-corrected visual acuity (BCVA), retinal sensitivity on microperimetry, and subjective scores on the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).;Primary end point(s): The primary endpoint of this study is to assess if there is a difference between half-dose PDT and eplerenone treatment in patients with cCSC, in terms of complete resolution of SRF on OCT. The assessment of this efficacy will be based on the anatomical effect on OCT: absence of SRF versus persistence of SRF, at 3 months after the initiation of treatment. ;Timepoint(s) of evaluation of this end point: At 3 months after the initiation of treatment

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At Evaluation Visit 1 (at 3 months after the start of trial treatment), at – if applicable – Evaluation Visit 2 (at 3 months after possible cross-over trial treatment), at Evaluation Visit 3 (one year after the start of trial treatment), and at the Final Evaluation Visit (two years after the start of trial treatment), compared to Baseline Evaluation; ;Secondary end point(s): As secondary endpoints, we will mainly look at 3 parameters that reflect the patient’s vision-related functioning. These 3 parameters are: a standardized measurement of ETDRS BCVA, a standardized measurement of sensitivity of the macula with microperimetry, and a standardized assessment of the patient’s vision-related quality of life using a validated questionnaire, the NEI-VFQ-25. The secondary endpoints that will be assessed as a reflection of functional improvement after treatment include: - Number of cross-over treatments (eplerenone after half-dose PDT, and half-dose PDT after eplerenone) needed in each treatment arm; - Mean change in ETDRS BCVA in the study eye at Evaluation Visit 1, at – if applicable – Evaluation Visit 2, at Evaluation Visit 3, and at the Final Evaluation Visit, compared to Baseline Evaluation; - Mean change in ETDRS BCVA in the study eye at Evaluation Visit 3 and at Final Evaluation Visit among those with subsequent (cross-over) and those without subsequent treatment; - Mean change in retinal sensitivity in the study eye at Evaluation Visit 1, at – if applicable – Evaluation Visit 2, at Evaluation Visit 3, and at Final Evaluation Visit, compared to Baseline Evaluation; - Mean change in the NEI-VFQ-25 questionnaire at Evaluation Visit 1, at – if applicable – Evaluation Visit 2, at Evaluation Visit 3, and at Final Evaluation Visit, compared to Baseline Evaluation; - The long-term outcome both after successful treatment and after non-successful treatment (‘success’ is defined as the absence of SRF on OCT at Evaluation Visit	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At Evaluation Visit 1 (at 3 months after the start of trial treatment), at – if applicable – Evaluation Visit 2 (at 3 months after possible cross-over trial treatment), at Evaluation Visit 3 (one year after the start of trial treatment), and at the Final Evaluation Visit (two years after the start of trial treatment), compared to Baseline Evaluation; ;Secondary end point(s): As secondary endpoints, we will mainly look at 3 parameters that reflect the patient’s vision-related functioning. These 3 parameters are: a standardized measurement of ETDRS BCVA, a standardized measurement of sensitivity of the macula with microperimetry, and a standardized assessment of the patient’s vision-related quality of life using a validated questionnaire, the NEI-VFQ-25. The secondary endpoints that will be assessed as a reflection of functional improvement after treatment include: - Number of cross-over treatments (eplerenone after half-dose PDT, and half-dose PDT after eplerenone) needed in each treatment arm; - Mean change in ETDRS BCVA in the study eye at Evaluation Visit 1, at – if applicable – Evaluation Visit 2, at Evaluation Visit 3, and at the Final Evaluation Visit, compared to Baseline Evaluation; - Mean change in ETDRS BCVA in the study eye at Evaluation Visit 3 and at Final Evaluation Visit among those with subsequent (cross-over) and those without subsequent treatment; - Mean change in retinal sensitivity in the study eye at Evaluation Visit 1, at – if applicable – Evaluation Visit 2, at Evaluation Visit 3, and at Final Evaluation Visit, compared to Baseline Evaluation; - Mean change in the NEI-VFQ-25 questionnaire at Evaluation Visit 1, at – if applicable – Evaluation Visit 2, at Evaluation Visit 3, and at Final Evaluation Visit, compared to Baseline Evaluation; - The long-term outcome both after successful treatment and after non-successful treatment (‘success’ is defined as the absence of SRF on OCT at Evaluation Visit

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Countries

Netherlands

Contacts

Public ContactClinical Trial Information

Leiden University Medical Center

31715299431

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026