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Retinal DiseasePhase 1/2CSC-ExtNCT01227993

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

A Phase 1/2 study testing Finasteride in people with Retinal Disease, run by National Eye Institute (NEI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Central serous chorioretinopathy (CSC) is a disease in which fluid accumulates under the retina and can cause distorted vision. CSC often resolves on its own without treatment, but in chronic CSC the fluid persists and can lead to permanent visual loss. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Disease
What is being tested?
Finasteride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Oct 2010to Jun 2013
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy, and demonstrated clinical improvement, as indicated by a reduction in subretinal fluid as measured on OCT.
  • Participant has subretinal fluid present in the macula that has a volume of at least 0.1 microliter causing visual change (such as reduced acuity, metamorphopsia or microperimetry deficits) and warrants treatment.
  • Participant must understand and sign the protocol's informed consent document.
  • 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. [All of the NCT00837252 (NIH protocol 09-EI-0075) participants were male given the male predilection of this disease.]

Who cannot join

  • Participant has abnormal liver function testing (LFT) 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 greater than 82 U/L and/or AST greater than 68 U/L). If a participant has ALT or AST levels greater than twice the ULN, the participant can be enrolled only if cleared by hepatology.
  • Participant is on steroid medication (oral, topical or inhaled).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Background:

  • Central serous chorioretinopathy (CSC) is a disease in which fluid accumulates under the retina and can cause distorted vision. CSC often resolves on its own without treatment, but in chronic CSC the fluid persists and can lead to permanent visual loss. Chronic CSC may be partly caused by hormones called androgens.
  • Finasteride is a drug that can modulate the effects of androgens; currently it is marketed as a treatment for male pattern baldness and benign prostate enlargement. The results of a previous brief study suggest that finasteride is safe and may help reduce the effects of chronic CSC. However, more long-term data are needed to evaluate whether finasteride is a safe and effective treatment for chronic CSC.
Read more

Objectives:

  • To collect more data on the safety and effectiveness of finasteride as a treatment for chronic central serous chorioretinopathy.

Eligibility:

  • Individuals who previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy, and demonstrated clinical improvement on finasteride treatment.

Design:

  • The study requires 11 visits to the NEI outpatient clinic over 5 years, with visits occurring every 6 months. Participants will be screened with a medical history, physical examination, eye examination, and blood and urine tests.
  • At each visit, participants will receive a supply of finasteride pills to take every day and will need to bring any leftover finasteride pills to the following visit.
  • Participants will have eye examinations to test vision, eye pressure, eye movements, and retinal thickness. Additional eye examinations will evaluate the retina's sensitivity to light and study the blood vessels and flow of blood in the eyes.
  • Blood and urine samples will be taken throughout the study.
  • After the end of the study, participants may be able to speak to their doctor about continuing finasteride treatments with a prescription.
Read the detailed description

Objective: Central serous chorioretinopathy (CSC) is a choroidal 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 may be involved. A recent study NCT00837252 (NIH protocol 09-EI-0075), "Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy," suggested that finasteride, an androgen modulating medication that is widely used in the treatment of various other conditions, may be efficacious as a treatment for chronic CSC. The objective of this study is to continue evaluation of participants in the completed NCT00837252 (NIH protocol 09-EI-0075) who clinically responded to treatment with finasteride.

Study Population: Up to five participants previously enrolled in NCT00837252 (NIH protocol 09-EI-0075) who demonstrated clinical improvement on finasteride treatment.

Design: This is a 5-year pilot extension study to allow participants who demonstrated clinical improvement with finasteride for chronic CSC to continue receiving finasteride as an off-label treatment. Study visits will occur every six months over the 5-year duration. Participants will receive finasteride when they have serous fluid present, unless deemed chronic non-responders (defined as serous fluid unchanged as compared to baseline or serous fluid stabilized with no further improvement while on finasteride treatment).

Outcome Measures: The primary outcome will be the change in best-corrected visual acuity (BCVA) at two years compared to baseline. Secondary outcome measures include the annual changes in BCVA, changes in subretinal fluid volume as measured on optical coherence tomography (OCT) (a 30% reduction in subretinal fluid from baseline is considered a "treatment success" by NEI standards), changes in leakage as observed on fluorescein angiography (FA), changes in plaque size as observed on indocyanine green angiography (ICG), changes in fundus autofluorescence patterns as observed on fundus autofluorescence (FAF) imaging, changes in microperimetry patterns, changes in serum levels of testosterone and dihydrotestosterone (DHT), as well as changes in urine levels of cortisol.

Conditions
Retinal Disease
Being tested
Finasteride
Keywords
Central Serous Chorioretinopathy, Finasteride, Proscar, Retinal Eye Disease
Medical subject headings
Retinal Diseases, Central Serous Chorioretinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FinasterideDrug

    Also called Proscar, Proprecia

Study groups in NCT01227993
Study groupRoleWhat they receive
FinasterideExperimentalParticipants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Receives: Drug: Finasteride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline

    Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. 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 equivalent Snellen measurement is 20/20.

    Measured: Baseline and 2 years

Secondary outcomes (14)

  1. Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline

    Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. 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 equivalent Snellen measurement is 20/20.

    Measured: Baseline and 2 years

  2. Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline

    Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. 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 equivalent Snellen measurement is 20/20.

    Measured: Baseline and 1 year

  3. Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline

    Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. 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 equivalent Snellen measurement is 20/20.

    Measured: Baseline and 1 year

  4. Change in Serum Testosterone Levels at Two Years Compared to Baseline

    The concentration of testosterone in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in nanograms of testosterone per decaliter of serum.

    Measured: Baseline and 2 years

  5. Change in Serum DHT Levels at Two Years Compared to Baseline

    The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in picograms of DHT per milliliter of serum.

    Measured: Baseline and 2 years

  6. Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline

    The amount of cortisol found in urine was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in micrograms.

    Measured: Baseline and 2 years

  7. Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline

    Measured: Baseline and 2 years

  8. Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline

    Measured: Baseline and 2 years

  9. Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline

    Measured: Baseline and 2 years

  10. Change in Area of Leakage in the Fellow Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline

    Measured: Baseline and 2 years

  11. Change in Plaque Size in the Study Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline

    Measured: Baseline and 2 years

  12. Change in Plaque Size in the Fellow Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline

    Measured: Baseline and 2 years

  13. Change in Autofluorescence Patterns in the Study Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline

    Measured: Baseline and 2 years

  14. Change in Autofluorescence Patterns in the Fellow Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline

    Measured: Baseline and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2012
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01227993
Sponsor's protocol ID
110012
Other IDs
11-EI-0012
Acronym
CSC-Ext
Status last verified
Oct 2013
First submitted
22 Oct 2010
Last updated
30 Jan 2024
Data monitoring committee
No

Publications

  • Gomolin JE. Choroidal neovascularization and central serous chorioretinopathy. Can J Ophthalmol. 1989 Feb;24(1):20-3.

    PubMed 2469527

  • Tewari HK, Gadia R, Kumar D, Venkatesh P, Garg SP. Sympathetic-parasympathetic activity and reactivity in central serous chorioretinopathy: a case-control study. Invest Ophthalmol Vis Sci. 2006 Aug;47(8):3474-8. doi: 10.1167/iovs.05-1246.

    PubMed 16877418

  • Spahn C, Wiek J, Burger T, Hansen L. Psychosomatic aspects in patients with central serous chorioretinopathy. Br J Ophthalmol. 2003 Jun;87(6):704-8. doi: 10.1136/bjo.87.6.704.

    PubMed 12770965

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Finasteride in people with Retinal Disease, run by National Eye Institute (NEI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline (time frame: Baseline and 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01227993, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

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