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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy

NCTNCT02693119 (opens ClinicalTrials.gov in a new tab)Other idSPILH-201
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
12 participants (actual)
Sponsor
Stealth BioTherapeutics Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Mar 2016
Primary completion
Sept 2019
Completion
Dec 2019
First posted
26 Feb 2016 (estimated)
Last update posted
30 Nov 2021
Conditions
Leber's Hereditary Optic Neuropathy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph 2

    A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy

    NCT02693119

    Mar 2016 to Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase 2, prospective, randomized, double-masked, vehicle controlled, single-center study in approximately 12 subjects with LHON to evaluate safety, tolerability and efficacy of elamipretide (MTP-131) topical ophthalmic solution in this patient population. At the conclusion of 52 weeks of treatment, subjects will be offered the opportunity to enter an Open Label Extension for up to 48 additional weeks of treatment.

Interventions

  • elamipretide (MTP-131) 1% topical ophthalmic solutionDrug
  • Vehicle topical ophthalmic solutionDrug

Arms4

  • Experimental

    Group 1

    One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to the left eye (OS) and one drop of vehicle topical ophthalmic solution BID in the fellow eye

  • Experimental

    Group 2

    One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to the right eye (OD) and one drop of vehicle topical ophthalmic solution BID in the fellow eye

  • Experimental

    Group 3

    One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU).

  • Experimental

    OLE

    One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU).

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Double Masked Period: Incidence of Ocular TEAEs

    Time frame · Assessed at each visit: Baseline, Day 5 Visit, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (End of treatment visit) and Week 56 (Follow up visit)

    Registry description

    The incidence of ocular treatment emergent adverse events (TEAEs).

  2. Open Label Extension: Incidence of Ocular TEAEs

    Time frame · Assessed at Week 68, 84, 100, 116, 132, 148, 152, Week 160/ (End of treatment visit)

    Registry description

    Open Label Extension: The incidence of ocular treatment emergent adverse events (TEAEs).

  3. Double Masked Period: Severity of Ocular TEAEs

    Time frame · Assessed at each visit: Baseline, Day 5 Visit, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (End of treatment visit) and Week 56 (Follow up visit)

    Registry description

    The severity of ocular treatment emergent adverse events (TEAEs).

  4. OLE: Severity of Ocular TEAEs

    Time frame · Assessed at Week 68, 84, 100, 116, 132, 148, 152, Week 160/ (End of treatment visit)

    Registry description

    The severity of ocular treatment emergent adverse events (TEAEs).

  5. Double Masked Period: Best Corrected Visual Acuity (BCVA)

    Time frame · Assessed at each visit: Baseline, Day 5 Visit, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (End of treatment visit) and Week 56 (Follow up visit)

    Registry description

    Double Masked Period: 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).

  6. Open Label Extension Period: Best Corrected Visual Acuity (BCVA) Using the Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale

    Time frame · Assessed at each visit from Baseline from Week 68 to Week 160 (follow-up visit).

    Registry description

    Open Label Extension Period: 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).

Secondary outcomes(20)

  1. Double Masked Period: Photopic Negative Response Electroretinography (PhNR-ERG) A-wave Amplitude

    Time frame · Assessed at each visit from Baseline to Week 56 (follow-up visit), except for Day 5 visit.

    Registry description

    Change from baseline in photopic negative response electroretinography (PhNR-ERG) a-wave amplitude by Visit. Photopic negative response electroretinography (PhNR-ERG) assesses retinal cell function. A decrease in the amplitude of the a-wave is associated with worse outcomes. Change from baseline in a-wave amplitude: a more positive number equals a decrease in amplitude, and therefore a worse outcome, a more negative number mean a better outcome.

  2. Open Label Extension Period: Photopic Negative Response Electroretinography (PhNR-ERG) A-wave Amplitude

    Time frame · Assessed at each visit from Baseline from Week 68 to Week 160

    Registry description

    Change from baseline in photopic negative response electroretinography (PhNR-ERG) a-wave Amplitude by Visit. Photopic negative response electroretinography (PhNR-ERG) assesses retinal cell function. A decrease in the amplitude of the a-wave is associated with worse outcomes. Change from baseline in a-wave amplitude: a more positive number equals a decrease in amplitude, and therefore a worse outcome, a more negative number mean a better outcome.

  3. Double Masked Period: Photopic Negative Response Electroretinography (PhNR-ERG) B-wave Amplitude

    Time frame · Assessed at each visit from Baseline to Week 56 (follow-up visit), except for Day 5 visit.

    Registry description

    Change from baseline in photopic negative response electroretinography (PhNR-ERG) b-wave amplitude by visit. Photopic negative response electroretinography (PhNR -ERG) assesses retinal cell function. A decrease in the amplitude of the b-wave is associated with worse outcomes. Change from baseline in b-wave amplitude: a more negative number equals a decrease in amplitude, and therefore a worse outcome, a more positive number mean a better outcome.

  4. Open Label Extension Period: PhNR-ERG B-wave Amplitude

    Time frame · Assessed at each visit from Baseline from Week 68 to Week 160

    Registry description

    Change from baseline in photopic negative response electroretinography (PhNR-ERG) b-wave Amplitude by Visit. Photopic negative response electroretinography (PhNR -ERG) assesses retinal cell function. A decrease in the amplitude of the b-wave is associated with worse outcomes. Change from baseline in b-wave amplitude: a more negative number equals a decrease in amplitude, and therefore a worse outcome, a more positive number means a better outcome.

  5. Double Masked Period: PhNR Amplitude

    Time frame · Assessed at each visit from Baseline to Week 56 (follow-up visit), except for Day 5 visit.

    Registry description

    Double Masked Period: Change from baseline in PhNR Amplitude by Visit. Photopic negative response electroretinography (PhNR -ERG) assesses retinal cell function. A decrease in PhNR amplitude means worse outcome. Change from baseline: A more negative number means a better outcome, a more positive number means a worse outcome.

  6. Open Label Extension Period: PhNR Amplitude

    Time frame · Assessed at each visit from Baseline from Week 68 to Week 160

    Registry description

    Open Label Extension Period: Change from baseline in PhNR Amplitude by Visit. Photopic negative response electroretinography (PhNR -ERG) assesses retinal cell function. A decrease in PhNR amplitude means worse outcome. Change from baseline: A more negative number means a better outcome, a more positive number means a worse outcome.

  7. Double Masked Period: PhNR/B-wave Amplitude Ratio

    Time frame · Assessed at each visit from Baseline to Week 56 (follow-up visit), except for Day 5 visit.

    Registry description

    Double Masked Period: Change from baseline in PhNR/b-wave amplitude ratio by Visit. Photopic negative response electroretinography (PhNR assesses retinal cell function. A decrease in PhNR amplitude means worse outcome.

  8. Open Label Extension Period: Change From Baseline by Visit PhNR/b Wave Amplitude Ratio

    Time frame · Assessed at each visit from Baseline from Week 68 to Week 160

    Registry description

    Open Label Extension Period: Change from baseline by visit PhNR/b Wave Amplitude Ratio by visit. A reduced amplitude ratio equals worse outcome.

  9. Double Masked Period: Change From Baseline by Visit PhNR Peak to Trough Adjusted for A-wave Amplitude

    Time frame · Assessed at each visit from Baseline to Week 56 (follow-up visit), except for Day 5 visit.

    Registry description

    Double Masked Period: Change from baseline by visit in PhNR Peak to Trough Adjusted for a-wave Amplitude by Visit. Calculated as (b-wave amplitude - PhNR amplitude)/a-wave amplitude. A reduced amplitude ratio equals worse outcome.

  10. Open Label Extension Period: Change From Baseline by Visit PhNR Peak to Trough Adjusted for A-wave Amplitude

    Time frame · Assessed at each visit from Baseline from Week 68 to Week 160

    Registry description

    Open Label Extension Period: Change from baseline by visit in PhNR Peak to Trough Adjusted for a-wave Amplitude by Visit. \[Calculated by b-wave amplitude - PhNR amplitude)/a-wave amplitude.\] Photopic negative response electroretinography (PhNR-ERG) assesses retinal cell function. A decrease in the amplitude of the a-wave is associated with worse outcomes. A reduced amplitude ratio equals worse outcome.

  11. Double Masked Period: PhNR Peak to Trough Amplitude (Unadjusted) From Baseline

    Time frame · Assessed at each visit from Baseline to Week 56 (follow-up visit), except for Day 5 visit.

    Registry description

    Double Masked Period: Change from baseline in PhNR Peak to Trough Amplitude (Unadjusted) by Visit. Calculated as b-wave amplitude - PhNR amplitude. Photopic negative response electroretinography (PhNR-ERG) assesses retinal cell function. A decrease in amplitude is associated with worse outcomes.

  12. Open Label Extension Period: PhNR Peak to Trough Amplitude (Unadjusted)

    Time frame · Assessed at each visit from Baseline from Week 68 to Week 160

    Registry description

    Open Label Extension Period: Change from baseline in PhNR Peak to Trough Amplitude (Unadjusted) by Visit. b-wave amplitude - PhNR amplitude. Photopic negative response electroretinography (PhNR-ERG) assesses retinal cell function. A decrease in the amplitude of the a-wave is associated with worse outcomes.

  13. Double Masked: VFQ-39 Composite

    Time frame · Assessed at Baseline, Week 52 (end-of-treatment visit) and Week 56 (follow-up visit)

    Registry description

    Double Masked: Change from baseline in Visual Function Questionnaire (VFQ-39) Composite score by visit. National Eye Institute VFQ-39 measures health-related quality of life in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, peripheral vision, and composite score. For each domain: the lowest and highest possible scores are 0 and 100 points, respectively. Higher score means higher functioning. Scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. For the composite score, the vision-targeted sub-scale scores are averaged, excluding the general health questions. Domain scores from each cohort are averaged and the change from baseline per domain is calculated.

  14. Open Label Extension Period: VFQ-39 Composite Score

    Time frame · Assessed at Baseline, Week 160 (End of OLE Period)

    Registry description

    Change from baseline in Visual Function Questionnaire (VFQ-39) Composite score.National Eye Institute VFQ-39 measures health-related quality of life in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, peripheral vision, and composite score. For each domain: the lowest and highest possible scores are 0 and 100 points, respectively. Higher score means higher functioning. Scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. For the composite score, the vision-targeted sub-scale scores are averaged, excluding the general health questions. Domain scores from each cohort are averaged and the change from baseline per domain is calculated.

  15. Open Label Extension Period: VFQ-39 General Health Score

    Time frame · Assessed at Baseline, Week 160 (End of OLE Period)

    Registry description

    Change from baseline in Visual Function Questionnaire (VFQ-39) General Health score. National Eye Institute VFQ-39 score measures health-related quality of life of subjects with visual impairment, in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, and peripheral vision and 1 composite score. Each domain is converted to a 0 to 100 scale; the lowest and highest possible scores are set at 0 and 100 points, respectively. Higher score means higher functioning. Scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. For the composite score, the vision-targeted sub-scale scores are averaged, excluding the general health questions. Domain scores from each cohort are averaged and the change from baseline per domain is calculated.

  16. Double Masked: VFQ-39 General Vision Score

    Time frame · Assessed at Baseline, Week 52 (end-of-treatment visit) and Week 56 (follow-up visit)

    Registry description

    Change from baseline in VFQ-39 General Vision Score. National Eye Institute VFQ-39 score measures health-related quality of life of subjects with visual impairment, in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, and peripheral vision and 1 composite score. Each domain is converted to a 0 to 100 scale; the lowest and highest possible scores are set at 0 and 100 points, respectively. Higher score means higher functioning. Scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. For the composite score, the vision-targeted sub-scale scores are averaged, excluding the general health questions. Domain scores from each cohort are averaged and the change from baseline per domain is calculate

  17. Open Label Extension Period: VFQ-39 General Vision Score

    Time frame · Assessed at Baseline, Week 160 (End of OLE Period)

    Registry description

    Change from baseline in VFQ-39 General Vision score. National Eye Institute VFQ-39 score measures health-related quality of life of subjects with visual impairment, in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, and peripheral vision and 1 composite score. Each domain is converted to a 0 to 100 scale; the lowest and highest possible scores are set at 0 and 100 points, respectively. Higher score means higher functioning. Scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. For the composite score, the vision-targeted sub-scale scores are averaged, excluding the general health questions. Domain scores from each cohort are averaged and the change from baseline per domain is calculate

  18. Double Masked: VFQ-39 Ocular Pain Score

    Time frame · Assessed at Baseline, Week 52 (end-of-treatment visit) and Week 56 (follow-up visit)

    Registry description

    Change from baseline in VFQ-39 Ocular Pain score. National Eye Institute VFQ-39 measures health-related quality of life in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, peripheral vision, and composite score. For each domain: the lowest and highest possible scores are 0 and 100 points, respectively. Higher score means higher functioning. Scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. For the composite score, the vision-targeted sub-scale scores are averaged, excluding the general health questions. Domain scores from each cohort are averaged and the change from baseline per domain is calculated.

  19. Open Label Extension Period: VFQ-39 Ocular Pain Score

    Time frame · Assessed at Baseline, Week 160 (End of OLE Period)

    Registry description

    Change from baseline in VFQ-39 Ocular Pain score by visit. National Eye Institute VFQ-39 measures health-related quality of life in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, peripheral vision, and composite score. For each domain: the lowest and highest possible scores are 0 and 100 points, respectively. Higher score means higher functioning. Scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. For the composite score, the vision-targeted sub-scale scores are averaged, excluding the general health questions. Domain scores from each cohort are averaged and the change from baseline per domain is calculated.

  20. Double Masked: VFQ-39 Near Activities Score

    Time frame · Assessed at Baseline, Week 52 (end-of-treatment visit) and Week 56 (follow-up visit)

    Registry description

    Change from Baseline in VFQ-39 Near Activities Score from Baseline. National Eye Institute VFQ-39 measures health-related quality of life in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, peripheral vision, and composite score. For each domain: the lowest and highest possible scores are 0 and 100 points, respectively. Higher score means higher functioning. Scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. For the composite score, the vision-targeted sub-scale scores are averaged, excluding the general health questions. Domain scores from each cohort are averaged and the change from baseline per domain is calculated.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Assessed at each visit: Baseline, Day 5 Visit, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (End of treatment visit) and Week 56 (Follow up visit)

Double Masked Period: Incidence of Ocular TEAEs

GroupValue (eyes)
Double Masked Group Vehicle Eyes3
Double Masked Group Elamipretide Eyes8
Primary outcomeNumber· Assessed at Week 68, 84, 100, 116, 132, 148, 152, Week 160/ (End of treatment visit)

Open Label Extension: Incidence of Ocular TEAEs

GroupValue (eyes)
Double Masked Group Vehicle Eyes1
Double Masked Group Elamipretide Eyes1
Primary outcomeNumber· Assessed at each visit: Baseline, Day 5 Visit, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (End of treatment visit) and Week 56 (Follow up visit)

Double Masked Period: Severity of Ocular TEAEs

GroupValue (eyes)
Vehicle Eyes: Mild2
Vehicle Eyes: Moderate0
Vehicle Eyes: Severe0
Elamipretide Eyes: Mild1
Elamipretide Eyes: Moderate1
Elamipretide Eyes: Severe0
Primary outcomeNumber· Assessed at Week 68, 84, 100, 116, 132, 148, 152, Week 160/ (End of treatment visit)

OLE: Severity of Ocular TEAEs

GroupValue (eyes)
Vehicle to Elamipretide Eyes: Mild5
Vehicle to Elamipretide Eyes: Moderate0
Vehicle to Elamipretide Eyes: Severe0
Elamipretide to Elamipretide Eyes: Mild6
Elamipretide to Elamipretide Eyes: Moderate0
Elamipretide to Elamipretide Eyes: Severe0
Primary outcomeMean· Assessed at each visit: Baseline, Day 5 Visit, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (End of treatment visit) and Week 56 (Follow up visit)

Double Masked Period: Best Corrected Visual Acuity (BCVA)

GroupValue (letters)Spread
Double Masked Group Vehicle Eyes-3.19.34
Double Masked Group Elamipretide Eyes-0.54.50
Primary outcomeMean· Assessed at each visit from Baseline from Week 68 to Week 160 (follow-up visit).

Open Label Extension Period: Best Corrected Visual Acuity (BCVA) Using the Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale

GroupValue (letters)Spread
Vehicle to Elamipretide8.514.16
Elamipretide to Elamipretide6.007.18
Secondary and other outcome results(2)
Secondary outcomeMean· Assessed at each visit from Baseline to Week 56 (follow-up visit), except for Day 5 visit.

Double Masked Period: Photopic Negative Response Electroretinography (PhNR-ERG) A-wave Amplitude

GroupValue (µV)Spread
Vehicle Eyes0.06.61
Elamipretide Eyes1.36.81
Secondary outcomeMean· Assessed at each visit from Baseline from Week 68 to Week 160

Open Label Extension Period: Photopic Negative Response Electroretinography (PhNR-ERG) A-wave Amplitude

GroupValue (µV)Spread
Vehicle to Elamipretide Eyes3.29.24
Elamipretide to Elamipretide Eyes4.06.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
One Eye DM PeriodOne eye Double Masked (DM) Period One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to a single eye and one drop of vehicle topical ophthalmic solution BID in the fellow eye0 / 80 / 86 / 8
Both Eyes DM PeriodBoth eyes Double Masked (DM) One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU).0 / 40 / 43 / 4
(One Eye DM Period) OLEBoth eyes Open label Extension period One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU) (and one eye in DM period)0 / 80 / 87 / 8
(Both Eyes DM) OLE PeriodBoth eyes Open label Extension period One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU) (and both eyes in DM period)0 / 40 / 44 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Adults ≥18 and ≤ 50 years old at the time of loss of vision in the second eye. * Able to provide informed consent and willing to comply with all study visits and examinations * Diagnosis of LHON based on clinical and ophthalmic functional/anatomic test findings, and satisfactory documentation of the mitochondrial DNA mutation m.11778G\>A * Loss of vision in both eyes of ≥1 year and ≤10 years at the time of the Screening Visit and current clinically stable visual function (as assessed by the Investigator) * Able to self-administer eye drops as demonstrated at screening or having a care provider who can do so * Documentation of having satisfactorily completed at least two previous Humphrey automated visual field tests prior to screening. * Women of childbearing potential must agree to use birth control as specified in the protocol from the date they sign the informed consent form Exclusion Criteria: * Any other ocular pathology requiring treatment with prescription topical ophthalmic drops (e.g., glaucoma, dry eye) * Cup to disc ratio of \> 0.8 in either eye * Media opacity, suboptimal pupillary dilatation, or refractive error that interferes with adequate retinal imaging * Known to be immunocompromised or receiving systemic immunosuppression * 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 Other protocol-defined inclusion/exclusion criteria may apply.

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