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A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED) (SPIFD-101)

Primary Purpose

Fuchs' Corneal Endothelial Dystrophy (FCED)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Part A Elamipretide 1.0% Ophthalmic Solution

Part B Elamipretide 3.0% Ophthalmic Solution

Part A Placebo

Part B Placebo

About this trial

This is an interventional treatment trial for Fuchs' Corneal Endothelial Dystrophy (FCED) focused on measuring Fuchs' Corneal Endothelial Dystrophy, FCED, Ocuvia™, MTP-131

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults ≥18 years old at the time of Screening Visit
Diagnosis of FCED OU (both eyes) based on clinical and ophthalmic test findings
Clinical evidence of corneal edema OU diagnosed with FCED, including one or more of the following signs: corneal epithelial microcysts, corneal epithelial bullae, stromal folds, or stromal haze
Central corneal thickness of 550 μm to 700 μm (inclusive) in at least one eye diagnosed with FCED, as measured by ultrasonic pachymetry at the time of Screening Visit and Baseline Visit
Best-corrected distance visual acuity (BCVA) of 20/25 to 20/320 (inclusive) at the time of Screening Visit and Baseline Visit OU
Women of childbearing potential must agree to use birth control as specified in the protocol from the date they sign the informed consent form (ICF) until after the last study
Able to give informed consent and willing to comply with all study visits and examinations
Part B only: The presence of central endothelium, as determined by the investigator, with an area of contiguous endothelial cells within 1 mm of the central cornea as measured by confocal laser scanning microscopy (CLSM) or specular microscopy at the time of Screening Visit

Exclusion Criteria:

Corneal findings of any type (including, but not limited to, stromal haze or stromal scarring), in either eye, that, based on investigator's assessment, limit the probability of visual improvement after corneal deturgescence
Any ocular pathology requiring treatment with topical ophthalmic drops, with the exception of glaucoma or ocular hypertension
Use of topical hypertonic saline drops for 3 days prior to Screening and throughout the duration of the study
History of corneal disease (other than FCED) or corneal surgery in either eye
Current use or likely need for the use of contact lens at any time during the study
History of previous corneal or anterior segment surgery such as LASIK, photorefractive keratectomy, endothelial keratoplasty, penetrating keratoplasty cataract surgery or glaucoma surgery.
Any disease or medical condition that in the opinion of the investigator would prevent the subject from participating in the study or might confound study results
Participation in other investigational drug or device clinical trials within 30 days prior to enrollment, or planning to participate in any other investigational drug or device clinical trials within 30 days of study completion
Women who are pregnant or lactating
Part B only: Participation in Part A of SPIFD-101

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

Cincinnati Eye Institute
Ophthalmic Consultants of Boston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Elamipretide 1.0% Ophthalmic Solution Part A (Cohort 1)

Elamipretide 3.0% Ophthalmic Solution Part B (Cohort 2)

Placebo A

Part B Placebo

Arm Description

Part A Each subject will receive one drop of elamipretide 1.0% ophthalmic solution BID in the randomly selected study eye (Cohort 1).

Part B Each subject will receive one drop of elamipretide 3.0% ophthalmic solution BID in both the right and left study eyes (Cohort 2).

Part A: Each subject will receive one drop of vehicle solution BID in the paired eye of the randomly selected study eye (Cohort 1).

Part B Each subject will receive one drop of vehicle solution BID in both the right and left study eyes (Cohort 2).

Outcomes

Primary Outcome Measures

Incidence and Severity of Ocular TEAEs.

The incidence and severity of ocular treatment emergent adverse events (TEAEs)

The Incidence and Severity of Systemic Adverse Events

The incidence and severity of systemic treatment emergent adverse events (TEAEs)

Change From Baseline in Findings From Slit Lamp Examinations (SLE) Part A

Number of participants who had a change from baseline from normal or abnormal not clinically significant, to abnormal clinically significant (CS) findings for slit lamp examinations (SLE) for Part A. Part B is reported as separate outcome since unit of measure is number of eyes.

Change From Baseline in Findings From Slit Lamp Examinations (SLE) Part B

Number of eyes with a change from baseline from normal or abnormal not clinically significant, to abnormal clinically significant (CS) findings for slit lamp examinations (SLE) for Part B. Part A is reported as separate outcome.

Change From Baseline in Intraocular Pressure (IOP) for Part A

Change from Baseline in intraocular pressure (IOP) using Goldmann applanation tonometry for Part A

Change From Baseline in Intraocular Pressure (IOP) for Part B

Change from Baseline in intraocular pressure (IOP) using Goldmann applanation tonometry for Part B. Part A is reported separately.

Secondary Outcome Measures

Change From Baseline in Central Corneal Thickness by Visit Part A as Measured by Pachymetry for Part A

Change from Baseline in Central Corneal Thickness by Visit as measured by Pachymetry for Part A. Part B is reported as a separate outcome measure.

Central Corneal Thickness Part B

Central Corneal Thickness: by-subject data as measured by Pachymetry and Pentacam. Part A is reported as a separate outcome measure.

Change From Baseline Endothelial Cell Hexagonality in Percentage Over All 12 Weeks for Part A

Change From Baseline in Endothelial Cell Hexagonality in Percentage Over All 12 Weeks for Part A. Specular microscopy is a noninvasive photographic technique that allows visualization and analyzation the corneal endothelium. Using computer-assisted morphometry, specular microscopes analyzes the size, shape and population of the endothelial cells. Histologically, healthy corneal cells initially have a hexagonal shape. As endothelial cells die, neighboring cells enlarge to cover the empty space once occupied by the cell. This, in turn, causes the remaining cells to lose their hexagonal shape. Assessments were performed using the flex center and full auto methods for Part A and data from the flex center method was summarized. The flex center method was used for Part B. The percent of Part B is entered as a separate outcome measure. A decrease from baseline in % cell hexagonality means worse outcome, a increase from baseline means better outcome.

Corneal Endothelial Cell Hexagonality Part B

Corneal Endothelial Cell Hexagonality in Percentage by-subject data: Part B. Data was only listed in weeks where images were good enough quality to quantify. Specular microscopy is a noninvasive photographic technique that allows visualization and analyzation the corneal endothelium. Using computer-assisted morphometry, specular microscopes analyzes the size, shape and population of the endothelial cells. Histologically, healthy corneal cells initially have a hexagonal shape. As endothelial cells die, neighboring cells enlarge to cover the empty space once occupied by the cell. This, in turn, causes the remaining cells to lose their hexagonal shape. The flex center method was used for Part B. A decrease in percent of cell hexagonality from baseline means worse outcome, an increase from baseline means better outcome.

Change From Baseline in Best Corrected Visual Acuity (BCVA) Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale for Part A.

Best corrected visual acuity (BCVA) using the using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale by visit. ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome). Part B was listed separately.

Best Corrected Visual Acuity (BCVA) Score Using ETDRS Scale for Part B

Change From Baseline in Endothelial Cell Density Over All 12 Weeks for Part A

Change From Baseline in Endothelial Cell Counts, or density (Counts/mm^2) over all 12 weeks for Part A. Part B is entered as a separate outcome measure.

Corneal Endothelial Cell Density Part B

Corneal Endothelial Cell Density: Part B, By-subject data for all time points where images were readable. For all time points where there were "Poor Quality Images" or "too few cells to register", there were no data available, and these were not listed below.

Change From Baseline in Endothelial Cell Coefficient of Variation Over All 12 Weeks for Part A

Change From Baseline in Endothelial Cell Coefficient of Variation Over All 12 Weeks. Coefficient of variation (CV) is Standard deviation (SD) of cell area divided by the mean cell area of endothelial cell analyzed. CV represents the coefficient, or degree, of variation in the sizes of the endothelial cells (polymegethism). By measuring the variation in size between endothelial cells, the system can measure how much cell loss is occurring. The more variation, the worse the outcome. Part B is is entered as a separate outcome measure.

Coefficient of Variation (CoV) Part B

Part B, By-subject data for all time points where images were readable. For all time points where there were "Poor Quality Images" or "too few cells to register" there were no data available. CoV represents the coefficient, or degree, of variation in the sizes of the endothelial cells. By measuring the variation in size between endothelial cells, the system can measure how much cell loss is occurring. A CoV less than 40 is normal.

Change From Baseline in Corneal Area Affected by Microcysts for Part A

Change from Baseline in corneal area affected by microcysts by visit for Part A.

Corneal Area Affected by Microcysts: Part B

Corneal area affected by microcysts: by-subject data for Part B. No microcysts were present for any timepoints.

Change From Baseline in Corneal Bullae for Part A.

Count of participants in number, size and location of bullae by treatment. Part B is listed separately.

Corneal Bullae: Part B

Number, size and location of Corneal bullae: By-subject data: Part B.

Change From Baseline in Severity of Corneal Stromal Folds for Part A

Change from baseline in severity of corneal stromal folds by visit. Descriptive assessment made by Investigator; severity is not assessed using a scale.

Severity of Corneal Stromal Folds:Part B

Severity of corneal stromal folds by-subject data by visit. Descriptive assessment made by Investigator in the following categories: Not present, trace, mild.

Change From Baseline in Contrast Sensitivity (Log Score) for Part A

Change from Baseline in contrast sensitivity over all 12 weeks log score at 3, 6, 12, 18 cycles per degree (cpd) using Vector Vision's CSV-1000E. Standard tables for the VectorVision's CSV-1000E model were used to convert linear results to the log values. Lower log scores equals lower contrast sensitivity and worse outcome. Higher log scores mean higher contrast sensitivity and better outcome. For 3cpd, range is 0.7-2.08; 6 cpd: 0.91-2.29; 12 cpd: 0.61-1.99; 18cpd: 0.17-1.55, unless no gratings were visible. If no gratings were visible, .3 log was subtracted from the lowest score for 3, 6, and 12cpd. For 18cpd .01 log was used, or essentially 100% contrast.

Contrast Sensitivity for Part B; By-subject Data

Contrast Sensitivity log score at 3, 6, 12, 18 cycles per degree (cpd) using Vector Vision's CSV-1000E by-subject data, Part B. Part A is listed separately. Standard tables for the VectorVision's CSV-1000E model were used to convert linear results to the log values. Lower log scores equals lower contrast sensitivity and worse outcome. Higher log scores mean higher contrast sensitivity and better outcome. For 3cpd, range is 0.7-2.08; 6 cpd: 0.91-2.29; 12 cpd: 0.61-1.99; 18cpd: 0.17-1.55, unless no gratings were visible. If no gratings were visible, .3 log was subtracted from the lowest score for 3, 6, and 12cpd. For 18cpd .01 log was used, or essentially 100% contrast.

Full Information

NCT ID

NCT02653391

First Posted

December 20, 2015

Last Updated

August 20, 2021

Sponsor

Stealth BioTherapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02653391

Brief Title

A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)

Acronym

SPIFD-101

Official Title

Part A: a Prospective, Randomized, Double-masked, Vehicle Controlled, Paired-eye Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Elamipretide Topical Ophthalmic Solution in Subjects With Fuchs' Corneal Endothelial Dystrophy (FCED) Presenting With Mild to Moderate Corneal Edema Part B: a Prospective, Randomized, Double-masked, Vehicle Controlled, Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution in Subjects With FCED Presenting With Mild to Moderate Corneal Edema.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stealth BioTherapeutics Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase 1/2 prospective, randomized, double-masked, and vehicle-controlled trial in two parts to evaluate the safety, tolerability, and efficacy of elamipretide topical ophthalmic solution in patients with Fuchs' Corneal Endothelial Dystrophy (FCED) presenting with mild to moderate corneal edema.

Detailed Description

This is a Phase 1/2 trial in two parts. Part A is a prospective, randomized, double-masked, vehicle controlled, paired-eye study in approximately 16 subjects to evaluate safety, tolerability and efficacy of elamipretide 1.0% topical ophthalmic solution in patients with Fuchs' Corneal Endothelial Dystrophy (FCED) presenting with mild to moderate corneal edema. Part B is a prospective, randomized double-masked, vehicle controlled study in approximately 11 subjects to evaluate safety, tolerability, and efficacy of elamipretide 3.0% topical ophthalmic solution in patients with FCED presenting with mild to moderate corneal edema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fuchs' Corneal Endothelial Dystrophy (FCED)

Keywords

Fuchs' Corneal Endothelial Dystrophy, FCED, Ocuvia™, MTP-131

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Elamipretide 1.0% Ophthalmic Solution Part A (Cohort 1)

Arm Type

Experimental

Arm Description

Part A Each subject will receive one drop of elamipretide 1.0% ophthalmic solution BID in the randomly selected study eye (Cohort 1).

Arm Title

Elamipretide 3.0% Ophthalmic Solution Part B (Cohort 2)

Arm Type

Experimental

Arm Description

Part B Each subject will receive one drop of elamipretide 3.0% ophthalmic solution BID in both the right and left study eyes (Cohort 2).

Arm Title

Placebo A

Arm Type

Placebo Comparator

Arm Description

Part A: Each subject will receive one drop of vehicle solution BID in the paired eye of the randomly selected study eye (Cohort 1).

Arm Title

Part B Placebo

Arm Type

Placebo Comparator

Arm Description

Part B Each subject will receive one drop of vehicle solution BID in both the right and left study eyes (Cohort 2).

Intervention Type

Drug

Intervention Name(s)

Part A Elamipretide 1.0% Ophthalmic Solution

Other Intervention Name(s)

MTP-131, Bendavia

Intervention Description

Part A Each subject will receive one drop of elamipretide 1.0% ophthalmic solution BID in the randomly selected study eye.

Intervention Type

Drug

Intervention Name(s)

Part B Elamipretide 3.0% Ophthalmic Solution

Other Intervention Name(s)

MTP-131, Bendavia

Intervention Description

Part B Each subject will receive one drop of elamipretide 3.0% ophthalmic solution BID in both eyes.

Intervention Type

Drug

Intervention Name(s)

Part A Placebo

Intervention Description

Part A Each subject will receive one drop of vehicle ophthalmic solution BID in the paired eye of the randomly selected study eye.

Intervention Type

Drug

Intervention Name(s)

Part B Placebo

Intervention Description

Part B: Each subject will receive one drop of vehicle ophthalmic solution BID in both eyes.

Primary Outcome Measure Information:

Title

Incidence and Severity of Ocular TEAEs.

Description

The incidence and severity of ocular treatment emergent adverse events (TEAEs)

Time Frame

Screening Visit, Baseline (Day 1), Week 1, Week 4, Week 8, Week 12, and Week 16

Title

The Incidence and Severity of Systemic Adverse Events

Description

The incidence and severity of systemic treatment emergent adverse events (TEAEs)

Time Frame

Screening Visit, Baseline (Day 1), Week 1, Week 4, Week 8, Week 12, and Week 16

Title

Change From Baseline in Findings From Slit Lamp Examinations (SLE) Part A

Description

Time Frame

Baseline, Week 1, Week 4, Week 8, Week 12, and Week 16

Title

Change From Baseline in Findings From Slit Lamp Examinations (SLE) Part B

Description

Time Frame

Baseline, Week 1, Week 4, Week 8, Week 12, and Week 16

Title

Change From Baseline in Intraocular Pressure (IOP) for Part A

Description

Change from Baseline in intraocular pressure (IOP) using Goldmann applanation tonometry for Part A

Time Frame

Baseline, Week 1, Week 4, Week 8, Week 12

Title

Change From Baseline in Intraocular Pressure (IOP) for Part B

Description

Change from Baseline in intraocular pressure (IOP) using Goldmann applanation tonometry for Part B. Part A is reported separately.

Time Frame

Baseline, Week 1, Week 4, Week 8, Week 12 , and Week 16 or early discontinuation visit

Secondary Outcome Measure Information:

Title

Change From Baseline in Central Corneal Thickness by Visit Part A as Measured by Pachymetry for Part A

Description

Change from Baseline in Central Corneal Thickness by Visit as measured by Pachymetry for Part A. Part B is reported as a separate outcome measure.

Time Frame

Baseline, Week 1, Week 4, Week 8, Week 12, and Week 16

Title

Central Corneal Thickness Part B

Description

Central Corneal Thickness: by-subject data as measured by Pachymetry and Pentacam. Part A is reported as a separate outcome measure.

Time Frame

Baseline (Day 1), Week 1, Week 4, Week 8, Week 12, and Week 16, or Early discontinuation visit

Title

Change From Baseline Endothelial Cell Hexagonality in Percentage Over All 12 Weeks for Part A

Description

Time Frame

Baseline, Week 1, 4, 8, and 12

Title

Corneal Endothelial Cell Hexagonality Part B

Description

Time Frame

Baseline, Week 1, Week 4, Week 8, Week 12, and Week 16 or early discontinuation visit

Title

Change From Baseline in Best Corrected Visual Acuity (BCVA) Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale for Part A.

Description

Time Frame

Baseline, Weeks 1, 4, 8, 12, and 16

Title

Best Corrected Visual Acuity (BCVA) Score Using ETDRS Scale for Part B

Description

Time Frame

Baseline, Weeks 1, 4, 8, 12, and 16

Title

Change From Baseline in Endothelial Cell Density Over All 12 Weeks for Part A

Description

Change From Baseline in Endothelial Cell Counts, or density (Counts/mm^2) over all 12 weeks for Part A. Part B is entered as a separate outcome measure.

Time Frame

Baseline, Weeks 1, 4, 8, and 12

Title

Corneal Endothelial Cell Density Part B

Description

Time Frame

Baseline, Weeks 1, 4, 8, 12, and 16.

Title

Change From Baseline in Endothelial Cell Coefficient of Variation Over All 12 Weeks for Part A

Description

Time Frame

Baseline, Week 12

Title

Coefficient of Variation (CoV) Part B

Description

Time Frame

Baseline, Weeks 1, 4, 8,12, and 16

Title

Change From Baseline in Corneal Area Affected by Microcysts for Part A

Description

Change from Baseline in corneal area affected by microcysts by visit for Part A.

Time Frame

Baseline, Weeks 1, 4, 8, 12, and 16

Title

Corneal Area Affected by Microcysts: Part B

Description

Corneal area affected by microcysts: by-subject data for Part B. No microcysts were present for any timepoints.

Time Frame

Baseline, Weeks 1, 4, 8, 12, and 16, or early discontinuation visit

Title

Change From Baseline in Corneal Bullae for Part A.

Description

Count of participants in number, size and location of bullae by treatment. Part B is listed separately.

Time Frame

Baseline, Week 1, Week 4, Week 8, Week 12, Week 16

Title

Corneal Bullae: Part B

Description

Number, size and location of Corneal bullae: By-subject data: Part B.

Time Frame

Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, or early discontinuation visit

Title

Change From Baseline in Severity of Corneal Stromal Folds for Part A

Description

Change from baseline in severity of corneal stromal folds by visit. Descriptive assessment made by Investigator; severity is not assessed using a scale.

Time Frame

Baseline, Weeks 1, 4, 8, 12, and 16

Title

Severity of Corneal Stromal Folds:Part B

Description

Severity of corneal stromal folds by-subject data by visit. Descriptive assessment made by Investigator in the following categories: Not present, trace, mild.

Time Frame

Baseline, Week 1, 4, 8, 12, and 16, or early discontinuation visit

Title

Change From Baseline in Contrast Sensitivity (Log Score) for Part A

Description

Time Frame

Baseline, Week 1, 4, 8, 12 weeks

Title

Contrast Sensitivity for Part B; By-subject Data

Description

Time Frame

Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, or early discontinuation visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults ≥18 years old at the time of Screening Visit Diagnosis of FCED OU (both eyes) based on clinical and ophthalmic test findings Clinical evidence of corneal edema OU diagnosed with FCED, including one or more of the following signs: corneal epithelial microcysts, corneal epithelial bullae, stromal folds, or stromal haze Central corneal thickness of 550 μm to 700 μm (inclusive) in at least one eye diagnosed with FCED, as measured by ultrasonic pachymetry at the time of Screening Visit and Baseline Visit Best-corrected distance visual acuity (BCVA) of 20/25 to 20/320 (inclusive) at the time of Screening Visit and Baseline Visit OU Women of childbearing potential must agree to use birth control as specified in the protocol from the date they sign the informed consent form (ICF) until after the last study Able to give informed consent and willing to comply with all study visits and examinations Part B only: The presence of central endothelium, as determined by the investigator, with an area of contiguous endothelial cells within 1 mm of the central cornea as measured by confocal laser scanning microscopy (CLSM) or specular microscopy at the time of Screening Visit Exclusion Criteria: Corneal findings of any type (including, but not limited to, stromal haze or stromal scarring), in either eye, that, based on investigator's assessment, limit the probability of visual improvement after corneal deturgescence Any ocular pathology requiring treatment with topical ophthalmic drops, with the exception of glaucoma or ocular hypertension Use of topical hypertonic saline drops for 3 days prior to Screening and throughout the duration of the study History of corneal disease (other than FCED) or corneal surgery in either eye Current use or likely need for the use of contact lens at any time during the study History of previous corneal or anterior segment surgery such as LASIK, photorefractive keratectomy, endothelial keratoplasty, penetrating keratoplasty cataract surgery or glaucoma surgery. Any disease or medical condition that in the opinion of the investigator would prevent the subject from participating in the study or might confound study results Participation in other investigational drug or device clinical trials within 30 days prior to enrollment, or planning to participate in any other investigational drug or device clinical trials within 30 days of study completion Women who are pregnant or lactating Part B only: Participation in Part A of SPIFD-101 Other protocol-defined inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Raizman, MD

Organizational Affiliation

Ophthalmic Consultants of Boston

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Edward Holland, MD

Organizational Affiliation

Cincinnati Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Eye Institute

City

Edgewood

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

Ophthalmic Consultants of Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)

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