Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00837252
First received: February 4, 2009
Last updated: May 23, 2011
Last verified: May 2011
  Purpose

Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss. The pathogenesis of CSC is complex; however, systemic androgens have been implicated. Finasteride is an anti-androgen medication that is widely used in the treatment of various conditions. The objective of this study was to investigate the safety and potential efficacy of oral finasteride as a treatment for chronic CSC.

Five participants with chronic CSC were enrolled into this uncontrolled, unmasked, Phase I/II study. An oral dose of finasteride, 5 mg daily, was administered to all participants for three months.

Following this, finasteride was withheld and participants were observed for another three months. If a participant experienced a beneficial effect during the period in which he received finasteride and then experienced a relapse during the observation period, finasteride was re-instituted for the remaining period of the study. Relapse was defined as a return to the baseline maximum lesion height and/or return to baseline lesion volume.


Condition Intervention Phase
Retinal Disease
Drug: Finasteride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Change in Visual Acuity at Month 3 Compared to Baseline. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.


Secondary Outcome Measures:
  • Change in Visual Acuity at Month 6 Compared to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.

  • Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.

  • Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.

  • Change in Subretinal Fluid Volume at Month 3 Compared to Baseline [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume.

  • Change in Subretinal Fluid Volume at Month 6 Compared to Baseline [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume.

  • Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in picograms of DHT per milliliter of serum.

  • Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in picograms of DHT per milliliter of serum.

  • Change in Serum Testosterone Level at Month 3 Compared to Baseline [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in nanograms of testosterone per decaliter of serum.

  • Change in Serum Testosterone Level at Month 6 Compared to Baseline [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in nanograms of testosterone per decaliter of serum.

  • Change in Urinary Cortisol Level at Month 3 Compared to Baseline [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    The amount of cortisol found in urine was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in micrograms.

  • Change in Urinary Cortisol Level at Month 6 Compared to Baseline [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    The amount of cortisol found in urine was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in micrograms.


Enrollment: 5
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Finasteride Drug: Finasteride
Participants received 5mg of oral finasteride daily for three months.
Other Names:
  • Propecia
  • Proscar

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Participant-Level Inclusion Criteria

  1. Participant must be 18 years of age or older.
  2. Participant must understand and sign the protocol's informed consent document.
  3. Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must be willing to undergo monthly pregnancy tests throughout the study.
  4. Female participants of childbearing potential must agree to practice two* acceptable methods of birth control throughout the course of the study and for three months after their last oral dose of finasteride. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner).

    *Participants with hysterectomy or vasectomy are exempt from using two methods of birth control. However female participants with a tubal ligation are not exempt and are required to practice another acceptable method of birth control.

  5. Participant agrees to take the appropriate precautions to ensure that persons who are pregnant, nursing or of childbearing potential do not handle the finasteride tablets.

Participant-Level Exclusion Criteria

  1. Participant is in another investigational study and actively receiving study therapy.
  2. Participant is unable to comply with study procedures or follow-up visits.
  3. Participant has evidence of ocular disease other than CSC in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.).
  4. Participant has evidence of CNV.
  5. Participant has abnormal liver function testing as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels that are greater than twice the respective upper limits of normal (ULN), i.e., ALT > 82 U/L and/or AST > 68 U/L. If a participant has ALT or AST levels greater than twice the ULN, the participant can be enrolled if cleared by hepatology.
  6. Participant is expected to need ocular surgery during the course of the trial.
  7. Participant is on steroid medication (oral, topical or inhaled).
  8. Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve.
  9. Participant has a systemic condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).

Study Eye Inclusion Criteria

  1. Eligible participants must have chronic CSC in at least one eye as defined by all of the following criteria:

    1. The presence of subretinal fluid, as determined by spectral domain OCT, AND
    2. The subretinal fluid must have been present for at least three months, or there is a recurrence of subretinal fluid within the past three months, AND
    3. The presence of characteristic fluorescein angiographic or autofluorescence features of CSC, such as one or more pinpoint leaks and/or diffuse retinal pigment epitheliopathy. This eye will be referred to as the "study eye."
  2. Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs.
  3. Participant must have visual acuity between 20/25 and 20/400 in the study eye.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837252

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Catherine B Meyerle, MD National Eye Institute (NEI)
  More Information

Publications:
Responsible Party: Catherine Meyerle, MD/National Eye Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00837252     History of Changes
Other Study ID Numbers: 090075, 09-EI-0075
Study First Received: February 4, 2009
Results First Received: April 21, 2011
Last Updated: May 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
Central Serous Chorioretinopathy
Finasteride
Proscar
Retinal Eye Disease

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014