A Phase 1/2 interventional study of Finasteride in Retinal Disease, sponsored by National Eye Institute (NEI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by National Eye Institute (NEI) · Phase 1/2, Interventional, and Treatment
Background:
Objectives:
Eligibility:
Design:
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.
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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.]
EXCLUSION CRITERIA:
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).
Participants 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.
Drug: Finasteride
Also known as: Proscar, Proprecia
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.
Time frame: Baseline and 2 years
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.
Time frame: Baseline and 2 years
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.
Time frame: Baseline and 1 year
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.
Time frame: Baseline and 1 year
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.
Time frame: Baseline and 2 years
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.
Time frame: Baseline and 2 years
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.
Time frame: Baseline and 2 years
Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline
Time frame: Baseline and 2 years
Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline
Time frame: Baseline and 2 years
Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline
Time frame: Baseline and 2 years
Change in Area of Leakage in the Fellow Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline
Time frame: Baseline and 2 years
Change in Plaque Size in the Study Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline
Time frame: Baseline and 2 years
Change in Plaque Size in the Fellow Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline
Time frame: Baseline and 2 years
Change in Autofluorescence Patterns in the Study Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline
Time frame: Baseline and 2 years
Change in Autofluorescence Patterns in the Fellow Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline
Time frame: Baseline and 2 years
| Milestone | Finasteride |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
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.
| ETDRS letters | Finasteride |
|---|---|
| Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline | 0 ± 5.20 |
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.
| ETDRS letters | Finasteride |
|---|---|
| Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline | -1.00 ± 5.29 |
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.
| ETDRS letters | Finasteride |
|---|---|
| Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline | 0 ± 4.58 |
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.
| ETDRS letters | Finasteride |
|---|---|
| Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline | 0.33 ± 4.16 |
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.
| ng/dL | Finasteride |
|---|---|
| Change in Serum Testosterone Levels at Two Years Compared to Baseline | -28.67 ± 144.05 |
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.
| pg/mL | Finasteride |
|---|---|
| Change in Serum DHT Levels at Two Years Compared to Baseline | 10.67 ± 44.06 |
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.
| µg | Finasteride |
|---|---|
| Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline | 2.75 ± 5.16 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Finasteride | — | 0/3 (0%) | 3/3 (100%) |
| Event | Finasteride |
|---|---|
| Alanine aminotransferase increasedInvestigations | 1/3 |
| Aspartate aminotrasferase increasedInvestigations | 1/3 |
| BronchitisInfections and infestations | 1/3 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/3 |
| Libido decreasedPsychiatric disorders | 1/3 |
| Upper respiratory tract infectionInfections and infestations | 1/3 |
| Age, Categorical(Participants) | Finasteride |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Age, Continuous(years) | Finasteride |
|---|---|
| Mean | 53.3 ± 10.6 |
| Sex: Female, Male(Participants) | Finasteride |
|---|---|
| Female | 0 |
| Male | 3 |
| Region of Enrollment(participants) | Finasteride |
|---|---|
| United States | 3 |
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