Back to resultsFirst-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
LHA510 Ophthalmic Suspension
LHA510 Vehicle
Sponsored by
About this trial
This is an interventional basic science trial for Age-Related Macular Degeneration focused on measuring LHA510, First in human, Safety, Tolerability, Pharmacokinetics, Elderly, Age-Related Macular Degeneration, AMD, Ocular, Eye drop
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent.
Vital signs within the following ranges:
- oral body temperature between 35.0-37.5 °C
- systolic blood pressure, 90-150 mm Hg
- diastolic blood pressure, 50-90 mm Hg
- pulse rate, 40 - 100 bpm.
- Weigh at least 50 kg.
- Able to communicate well with the investigator.
- Able to understand and comply with the requirements of the study.
Additional eligibility criteria for Part 2 (AMD subjects):
- Evidence of AMD in one or both eyes.
- Age 55-90.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Any currently active ocular condition that requires use of topical eye drops.
- Use of contact lens over the course of the study.
- Abnormal corneal examination results at screening or eligibility.
- History of any ocular surgery within the past 6 months prior to study participation.
- Use of other investigational drugs within 30 days of enrollment.
- History of hypersensitivity or allergy to any of the study drugs (including fluorescein) or to drugs of similar chemical classes.
- History of clinically significant ECG abnormalities, or any ECG abnormality at screening or eligibility.
- Known history or current clinically significant arrhythmias.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Use of any prohibited medication as specified in the protocol.
- Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
- Low hemoglobin levels at screening or eligibility as specified in the protocol.
- Significant illness as specified in the protocol.
- History of drug or alcohol abuse within the 12 months prior to dosing.
Additional exclusion criteria for Part 1 (healthy subjects):
- Abnormal thickness of the central retinal subfield on OCT at screening.
- History of any chronic eye disease other than refractive error, incipient cataract, strabismic amblyopia, or anisometropic amblyopia.
Additional exclusion criteria for Part 2 (AMD subjects):
- Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab (Lucentis®), aflibercept (Eylea®), bevacizumab (Avastin®), pegaptanib (Macugen®), or any other VEGF inhibitor.
- Patients who have required and received regular monthly injections of these drugs in the months preceding the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
LHA510 Part 1
LHA510 Vehicle Part 1
LHA510 Part 2
LHA510 Vehicle Part 2
Arm Description
LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1
Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1
LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2
Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2
Outcomes
Primary Outcome Measures
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Subjects Experiencing a Non-serious Adverse Event, Part I
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Number of Subjects Experiencing a Non-serious Adverse Event, Part 2
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Secondary Outcome Measures
The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method.Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
The Terminal Elimination Half-life [Time] (T1/2), Part 2
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1
Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1
Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1
Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2
Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2
Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2
Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02076919
Brief Title
First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration
Official Title
A Randomized, Double-Masked, Vehicle-Controlled, First-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Topically Delivered LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this first-in-human study is to assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies.
Detailed Description
This first-in-human study was conducted in two parts. Part 1 was a single ascending dose (SAD) design to assess the local ocular and systemic safety and tolerability of a single topical eye drop of LHA510 administered at various concentrations. Four separate cohorts of unique elderly subjects (55 to 80 years) were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio as a single dose. A disposition evaluation was performed 7 days later. Part 2 was a multiple ascending dose (MAD) design to assess the local ocular and systemic safety and tolerability of LHA510 administered at various concentrations and dosing frequencies. Six separate cohorts of unique AMD subjects were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio for 7 days. A disposition evaluation was performed 14 days after the first dose of study drug. A review of all available safety data was conducted by the Sponsor and the PI(s) prior to dose escalation (cohort progression). The same concentrations levels were used in Part 1 and Part 2 and are ordered as Lowest, Next Lowest, Next Highest, and Highest.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
LHA510, First in human, Safety, Tolerability, Pharmacokinetics, Elderly, Age-Related Macular Degeneration, AMD, Ocular, Eye drop
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LHA510 Part 1
Arm Type
Experimental
Arm Description
LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1
Arm Title
LHA510 Vehicle Part 1
Arm Type
Placebo Comparator
Arm Description
Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1
Arm Title
LHA510 Part 2
Arm Type
Experimental
Arm Description
LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2
Arm Title
LHA510 Vehicle Part 2
Arm Type
Placebo Comparator
Arm Description
Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2
Intervention Type
Drug
Intervention Name(s)
LHA510 Ophthalmic Suspension
Intervention Description
Ophthalmic suspension in 4 concentration levels topically administered in Part 1 and Part 2
Intervention Type
Drug
Intervention Name(s)
LHA510 Vehicle
Intervention Description
Inactive ingredients used for masking purposes
Primary Outcome Measure Information:
Title
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1
Description
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame
From time of consent until 30 days after stopping the trial/study drug
Title
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2
Description
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame
From time of consent until 30 days after stopping the trial/study drug
Title
Number of Subjects Experiencing a Non-serious Adverse Event, Part I
Description
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Time Frame
From time of consent until 30 days after stopping the trial/study drug
Title
Number of Subjects Experiencing a Non-serious Adverse Event, Part 2
Description
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Time Frame
From time of consent until 30 days after stopping the trial/study drug
Secondary Outcome Measure Information:
Title
The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2
Description
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method.Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
Time Frame
Up to Day 15
Title
The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2
Description
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
Time Frame
Up to Day 15
Title
The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2
Description
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
Time Frame
Up to Day 15
Title
The Terminal Elimination Half-life [Time] (T1/2), Part 2
Description
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
Time Frame
Up to Day 15
Title
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1
Description
Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Time Frame
Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Title
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1
Description
Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Time Frame
Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Title
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1
Description
Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Time Frame
Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Title
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2
Description
Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Time Frame
Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Title
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2
Description
Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Time Frame
Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Title
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2
Description
Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Time Frame
Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent.
Vital signs within the following ranges:
oral body temperature between 35.0-37.5 °C
systolic blood pressure, 90-150 mm Hg
diastolic blood pressure, 50-90 mm Hg
pulse rate, 40 - 100 bpm.
Weigh at least 50 kg.
Able to communicate well with the investigator.
Able to understand and comply with the requirements of the study.
Additional eligibility criteria for Part 2 (AMD subjects):
Evidence of AMD in one or both eyes.
Age 55-90.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Any currently active ocular condition that requires use of topical eye drops.
Use of contact lens over the course of the study.
Abnormal corneal examination results at screening or eligibility.
History of any ocular surgery within the past 6 months prior to study participation.
Use of other investigational drugs within 30 days of enrollment.
History of hypersensitivity or allergy to any of the study drugs (including fluorescein) or to drugs of similar chemical classes.
History of clinically significant ECG abnormalities, or any ECG abnormality at screening or eligibility.
Known history or current clinically significant arrhythmias.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
Pregnant or nursing (lactating) women.
Women of child-bearing potential.
Use of any prohibited medication as specified in the protocol.
Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
Low hemoglobin levels at screening or eligibility as specified in the protocol.
Significant illness as specified in the protocol.
History of drug or alcohol abuse within the 12 months prior to dosing.
Additional exclusion criteria for Part 1 (healthy subjects):
Abnormal thickness of the central retinal subfield on OCT at screening.
History of any chronic eye disease other than refractive error, incipient cataract, strabismic amblyopia, or anisometropic amblyopia.
Additional exclusion criteria for Part 2 (AMD subjects):
Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab (Lucentis®), aflibercept (Eylea®), bevacizumab (Avastin®), pegaptanib (Macugen®), or any other VEGF inhibitor.
Patients who have required and received regular monthly injections of these drugs in the months preceding the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Maietta, BSc
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration
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