Trial Outcomes & Findings for Finasteride for Chronic Central Serous Chorioretinopathy (NCT NCT01585441)

NCT ID: NCT01585441

Last Updated: 2014-12-04

Results Overview

This is the regulatory filing primary outcome measure. 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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Month 3
• Results posted on: 2014-12-04

Participant Flow

Participant milestones

Measure	Finasteride 5 mg Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Overall Study STARTED	3	3
Overall Study Month 3	2	3
Overall Study Received Finasteride at Month 3	2	2
Overall Study Final Study Safety Visit	3	2
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Finasteride for Chronic Central Serous Chorioretinopathy

Baseline characteristics by cohort

Measure	Finasteride 5 mg n=3 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3

This is the regulatory filing primary outcome measure. 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.

Outcome measures

Measure	Finasteride 5 mg n=2 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.	0 participants	0 participants

PRIMARY outcome

Timeframe: Month 3

This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.

Outcome measures

Measure	Finasteride 5 mg n=2 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline	1 participants	0 participants

SECONDARY outcome

Timeframe: Duration of the study, up to 1.5 years

The outcome measure refers only to events that were classified as related to the investigational product.

Outcome measures

Measure	Finasteride 5 mg n=3 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Number of Participants With Adverse Reactions Related to the Investigational Product	0 participants	1 participants

SECONDARY outcome

Timeframe: Duration of the study, up to 1.5 years

Outcome measures

Measure	Finasteride 5 mg n=3 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Number of Participants Who Withdrew From the Study	0 participants	0 participants

SECONDARY outcome

Timeframe: Month 3

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.

A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.

Outcome measures

Measure	Finasteride 5 mg n=2 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline	1.00 ETDRS letters Standard Deviation 1.41	1.67 ETDRS letters Standard Deviation 2.08

SECONDARY outcome

Timeframe: Final Study Visit

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.

A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.

Outcome measures

Measure	Finasteride 5 mg n=3 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=2 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline	-3.33 ETDRS letters Standard Deviation 8.39	0.50 ETDRS letters Standard Deviation 0.71

SECONDARY outcome

Timeframe: Month 3

Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.

Outcome measures

Measure	Finasteride 5 mg n=2 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline	-37.50 percent change Standard Deviation 53.03	27.78 percent change Standard Deviation 63.10

SECONDARY outcome

Timeframe: Month 3

Microperimetry was used to assess macular sensitivity.

Outcome measures

Measure	Finasteride 5 mg n=2 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline	-2.00 decibels Standard Deviation 3.82	-1.40 decibels Standard Deviation 1.47

SECONDARY outcome

Timeframe: Final Study Visit

Microperimetry was used to assess macular sensitivity.

Outcome measures

Measure	Finasteride 5 mg n=3 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=2 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline	-2.03 decibels Standard Deviation 3.91	-2.45 decibels Standard Deviation 0.50

SECONDARY outcome

Timeframe: Month 3

Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).

Outcome measures

Measure	Finasteride 5 mg n=2 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline	-55.00 μm Standard Deviation 50.91	20.33 μm Standard Deviation 72.59

SECONDARY outcome

Timeframe: Final Study Visit

Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).

Outcome measures

Measure	Finasteride 5 mg n=3 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=2 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline	-39.67 μm Standard Deviation 93.30	50.50 μm Standard Deviation 41.72

SECONDARY outcome

Timeframe: Month 3

The mean change is reported in picograms of DHT per milliliter of serum.

Outcome measures

Measure	Finasteride 5 mg n=2 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline	-332.00 pg/mL Standard Deviation 176.78	-93.67 pg/mL Standard Deviation 113.50

SECONDARY outcome

Timeframe: Final Study Visit

The mean change is reported in picograms of DHT per milliliter of serum.

Outcome measures

Measure	Finasteride 5 mg n=3 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=2 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline	-101.67 pg/mL Standard Deviation 103.00	-337.50 pg/mL Standard Deviation 467.40

SECONDARY outcome

Timeframe: Month 3

The mean change is reported in nanograms of testosterone per decaliter of serum.

Outcome measures

Measure	Finasteride 5 mg n=2 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Change in Serum Testosterone Concentration at Month 3 Compared to Baseline	-33.50 ng/dL Standard Deviation 139.30	-29.67 ng/dL Standard Deviation 111.96

SECONDARY outcome

Timeframe: Final Study Visit

The mean change is reported in nanograms of testosterone per decaliter of serum.

Outcome measures

Measure	Finasteride 5 mg n=3 Eyes Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=2 Eyes Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline	-42.00 ng/dL Standard Deviation 194.51	33.00 ng/dL Standard Deviation 100.41

SECONDARY outcome

Timeframe: Month 3

The mean change is reported in micrograms (μg).

Outcome measures

Measure	Finasteride 5 mg n=2 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline	5.75 μg Standard Deviation 23.12	-7.10 μg Standard Deviation 16.71

SECONDARY outcome

Timeframe: Final Study Visit

Population: One finasteride participant's cortisol lab value could not be calculated due to Cortisol, Urine \<1.5 ng/mL.

The mean change is reported in micrograms (μg).

Outcome measures

Measure	Finasteride 5 mg n=2 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=2 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline	-0.60 μg Standard Deviation 3.53	0.70 μg Standard Deviation 6.08

SECONDARY outcome

Timeframe: Month 3

Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging

Outcome measures

Measure	Finasteride 5 mg n=2 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline	2 participants	3 participants

SECONDARY outcome

Timeframe: Final Study Visit

Population: One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.

Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging

Outcome measures

Measure	Finasteride 5 mg n=3 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=2 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline	3 participants	2 participants

SECONDARY outcome

Timeframe: Month 3

Outcome measures

Measure	Finasteride 5 mg n=2 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline	2 participants	3 participants

SECONDARY outcome

Timeframe: Final Study Visit

Population: One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.

Outcome measures

Measure	Finasteride 5 mg n=3 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=2 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline	3 participants	2 participants

SECONDARY outcome

Timeframe: Month 3

Changes in leakage as observed on fluorescein angiography (FA)

Outcome measures

Measure	Finasteride 5 mg n=2 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline	2 participants	2 participants

SECONDARY outcome

Timeframe: Final Study Visit

Changes in leakage as observed on fluorescein angiography (FA)

Outcome measures

Measure	Finasteride 5 mg n=3 Participants Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=2 Participants Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline	2 participants	2 participants

Adverse Events

Finasteride 5 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Finasteride 5 mg n=3 participants at risk Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Placebo n=3 participants at risk Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Nervous system disorders Dizziness	66.7% 2/3 • Number of events 2 • Duration of the study, up to 1.5 years	0.00% 0/3 • Duration of the study, up to 1.5 years
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Duration of the study, up to 1.5 years	0.00% 0/3 • Duration of the study, up to 1.5 years
Eye disorders Eye pruritis	33.3% 1/3 • Number of events 1 • Duration of the study, up to 1.5 years	0.00% 0/3 • Duration of the study, up to 1.5 years
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/3 • Duration of the study, up to 1.5 years	33.3% 1/3 • Number of events 1 • Duration of the study, up to 1.5 years
Injury, poisoning and procedural complications Ankle Fracture	33.3% 1/3 • Number of events 1 • Duration of the study, up to 1.5 years	0.00% 0/3 • Duration of the study, up to 1.5 years

Additional Information

Emily Chew, MD

National Eye Institute

Phone: 301-496-6583

Email: emily.chew@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place