Photodynamic Therapy Versus Eplerenone: Treatment Trial for Chronic Central Serous Chorioretinopathy

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Brief Title

Photodynamic Therapy Versus Eplerenone: Treatment Trial for Chronic Central Serous Chorioretinopathy

Official Title

Study on Half-dose Photodynamic Therapy Versus Eplerenone in Chronic CenTRAl Serous Chorioretinopathy (SPECTRA Trial)

Brief Summary

      Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye
      disease that is often diagnosed in patients in the professionally active age range. In this
      disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and
      the retinal pigment epithelium. This specific form of macular degeneration can cause
      permanent vision loss, image distortion, and loss of color and contrast vision. An early
      diagnosis and treatment may improve the visual outcome and quality of life.

      To date there is no international consensus on the optimal treatment of cCSC. Many
      retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in
      chronic CSC. Treatment with oral eplerenone may also be effective in this disease.

      In this proposed prospective randomized controlled trial, cCSC patients will be randomized
      into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The
      trial is a superiority study, because retrospective studies suggest that PDT treatment may be
      more effective than eplerenone treatment.

      The null hypothesis of the study is that PDT treatment is more effective than eplerenone
      treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is
      not superior to eplerenone treatment.

      Treatment success will not only be based on characteristics on ophthalmological imaging, but
      also on functional endpoints (both on the outcome of questionnaires, best-corrected visual
      acuity, and microperimetry), which are most important from a patient's perspective.

      The study will take place in 3 large tertiary referral university hospitals in The
      Netherlands that have extensive experience with conducting clinical trials (Academic Medical
      Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the
      Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the
      Radboud University Medical Center and the Leiden University Medical Center have been involved
      in the first prospective randomized controlled trial that is currently conducted in cCSC.

      This study will last 2 years per participant. Each participant will visit the outpatient
      clinic for a maximum number of 6 visits.

      A total number of 107 patients will be included in the trial. Depending on the speed of
      inclusion of patients in this trial, the total duration of this study can be determined.
    

Detailed Description

      Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye
      disease that is often diagnosed in patients in the professionally active age range. In this
      disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and
      the retinal pigment epithelium. This specific form of macular degeneration can cause
      permanent vision loss, image distortion, and loss of color and contrast vision. An early
      diagnosis and treatment may improve the visual outcome and quality of life.

      To date there is no international consensus on the optimal treatment of cCSC. Many
      retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in
      chronic CSC. Treatment with oral eplerenone may also be effective in this disease.

      In this proposed prospective randomized controlled trial, cCSC patients will be randomized
      into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The
      trial is a superiority study, because retrospective studies suggest that PDT treatment may be
      more effective than eplerenone treatment.

      The null hypothesis of the study is that PDT treatment is more effective than eplerenone
      treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is
      not superior to eplerenone treatment.

      Treatment success will not only be based on characteristics on ophthalmological imaging, but
      also on functional endpoints (both on the outcome of questionnaires, best-corrected visual
      acuity, and microperimetry), which are most important from a patient's perspective.

      The study will take place in 3 large tertiary referral university hospitals in The
      Netherlands that have extensive experience with conducting clinical trials (Academic Medical
      Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the
      Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the
      Radboud University Medical Center and the Leiden University Medical Center have been involved
      in the first prospective randomized controlled trial that is currently conducted in cCSC.

      This study will last 2 years per participant. Each participant will visit the outpatient
      clinic for a maximum number of 6 visits, depending on the outcome of treatment. Study
      evaluations will be mostly part of regular clinical care.

      A total number of 107 patients will be included in the trial. Depending on the speed of
      inclusion of patients in this trial, the total duration of this study can be determined.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Absence of subretinal fluid on OCT scan

Secondary Outcome

 Macular sensitivity on microperimetry

Condition

Chronic Central Serous Chorioretinopathy

Intervention

Eplerenone

Study Arms / Comparison Groups

 Half-dose photodynamic therapy (PDT)
Description:  In the PDT treatment arm, all patients will receive an intravenous drip through which half-dose (3 mg/m2) verteporfin (Visudyne®) is administered, with an infusion time of 10 minutes. At exactly 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689 nm, and a treatment duration of 83 seconds.
When patients are randomized to the PDT arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, PDT can be performed in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after the start of eplerenone treatment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

107

Start Date

February 20, 2017

Completion Date

August 2021

Primary Completion Date

August 28, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Age of ≥ 18 years of age and able to give written informed consent;

          -  Active chronic central serous chorioretinopathy (cCSC);

          -  Subjective visual loss > 6 weeks, interpreted as onset of active disease;

          -  Foveal subretinal fluid (SRF), on optical coherence tomography (OCT), at Baseline
             Examination;

          -  ≥1 ill-defined hyperfluorescent leakage areas on fluorescein angiography (FA) with
             retinal pigment epithelial window defect(s) that are compatible with cCSC;

          -  Hyperfluorescent areas on indocyanine green angiography (ICGA).

        Exclusion Criteria:

          -  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;

          -  Best-corrected visual acuity < 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 photodynamic 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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Camiel JF Boon, MD, PhD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT03079141

Organization ID

P16.255


Responsible Party

Principal Investigator

Study Sponsor

Leiden University Medical Center

Collaborators

 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Sponsor

Camiel JF Boon, MD, PhD, Principal Investigator, Leiden University Medical Center


Verification Date

October 2019