- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02355028
LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration
A Randomized, Double-Masked, Vehicle-Controlled Proof-Of-Concept Study for Topically Delivered LHA510 as a Maintenance Therapy in Patients With Wet Age-Related Macular Degeneration (AMD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Fort Worth, Texas, United States, 76134
- Contact Alcon Call Center for Trial Locations
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sign written informed consent form;
- Wet AMD;
- IVT anti-VEGF therapy for at least 6 months and a maximum of 7 years since the 3rd loading dose;
- BCVA 50 letters (approximate Snellen equivalent 20/100) or better in the study eye;
- Demonstrate ability to administer eye drops (subject or care-giver);
- CNV recently demonstrated high need for frequent anti-VEGF therapy and a sustained functional and clear anatomical response to the therapy in the study eye;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any active ocular or periocular infection or intraocular inflammation;
- Current or history of macular or retinal disease (if visually significant) other than wet AMD in the study eye;
- Current clinically significant vitreous hemorrhage or history of rhegmatogenous retinal detachment affecting the macula in the study eye;
- History of hypersensitivity to any of the study drugs or clinically relevant sensitivity to fluorescein dye or povidone iodine;
- Women of child-bearing potential;
- History of a medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or a safe administration of investigational product;
- Other protocol-specified exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LHA510
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
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For intravitreal (IVT) injection
Other Names:
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Placebo Comparator: Vehicle
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
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For intravitreal (IVT) injection
Other Names:
Inactive ingredients used as a placebo comparator
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84
Time Frame: Day 84
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For subjects who completed the Day 84 visit, retreatment need status was positive if LUCENTIS® retreatment (injection) was required before or at Day 84, including requiring retreatment at or before the Day 84 visit with the actual retreatment performed at a later visit.
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Day 84
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to First LUCENTIS® Retreatment Need Identification up to Day 84
Time Frame: Day 14, Day 28, Day 56, Day 84
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The time was determined based on the visit of the treatment period when a patient was identified as requiring retreatment with LUCENTIS.
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Day 14, Day 28, Day 56, Day 84
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Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84
Time Frame: Up to Day 84
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The number of LUCENTIS retreatment needs identified before or at the Day 84 visit (even if retreatment was applied at a later visit) for each patient was used in the analysis
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Up to Day 84
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Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56
Time Frame: Day 28, Day 56
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The number of LUCENTIS® retreatment needs identified before or at the Day 28 and Day 56 visits (even if retreatment was applied at a later visit) for each subject was used in the analysis.
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Day 28, Day 56
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Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site
Time Frame: Day -1, Day 14, Day 28, Day 56, Day 84
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The thickness of the retina was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1).
A negative number indicates a reduction in thickness, whereas a positive number indicates an increase.
An increase in thickness may indicate a progression of the underlying disease.
Only one eye (study eye) contributed to the analysis.
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Day -1, Day 14, Day 28, Day 56, Day 84
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Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site
Time Frame: Day -1, Day 14, Day 28, Day 56, Day 84
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Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity was conducted in each eye individually using ETDRS charts and reported in number of letters read correctly.
An increase (gain) in letters read from the baseline assessment indicates improvement.
Only one eye (study eye) contributed to the analysis.
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Day -1, Day 14, Day 28, Day 56, Day 84
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Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit
Time Frame: Day -1, Day 28, Day 84
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The thickness of the neuro-retina, at the level of the central subfield, was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1).
A negative number indicates a reduction in thickness, whereas a positive number indicates an increase.
An increase in thickness may indicate a progression of the underlying disease.
Only one eye (study eye) contributed to the analysis.
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Day -1, Day 28, Day 84
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Change From Randomization Visit (Day -1) in Lesion Thickness by Visit
Time Frame: Day -1, Day 28, Day 84
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The thickness of the neovascular lesion was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1).
A negative number indicates a reduction in thickness, whereas a positive number indicates an increase.
An increase in thickness of the neovascular lesion may indicate a progression of the underlying disease.
Only one eye (study eye) contributed to the analysis.
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Day -1, Day 28, Day 84
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Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit
Time Frame: Day -1, Day 28, Day 84
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The thickness of subretinal fluid involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1).
A negative number indicates a reduction in thickness, whereas a positive number indicates an increase.
An increase in thickness of subretinal fluid involving the fovea may indicate a progression of the underlying disease.
Only one eye (study eye) contributed to the analysis.
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Day -1, Day 28, Day 84
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Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit
Time Frame: Day -1, Day 28, Day 84
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The thickness of pigment epithelial detachment involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1).
A negative number indicates a reduction in thickness, whereas a positive number indicates an increase.
An increase in thickness of pigment epithelial detachment involving the fovea may indicate a progression of the underlying disease.
Only one eye (study eye) contributed to the analysis.
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Day -1, Day 28, Day 84
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Change From Randomization Visit (Day -1) in Total Lesion Size by Visit
Time Frame: Day -1, Day 84
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The total wet AMD lesion size was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1).
A negative number indicates a reduction, whereas a positive number indicates an increase.
An increase in wet AMD lesion size may indicate a progression of the underlying disease.
Only one eye (study eye) contributed to the analysis.
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Day -1, Day 84
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Change From Randomization Visit (Day -1) in CNV Size by Visit
Time Frame: Day -1, Day 84
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The size of CNV (area of new blood vessels in the choroid layer of the retina) was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1).
A negative number indicates a reduction, whereas a positive number indicates an increase.
An increase in CNV size may indicate a progression of the underlying disease.
Only one eye (study eye) contributed to the analysis.
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Day -1, Day 84
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Plasma Concentration of LHA510 and CRA398
Time Frame: Day 28, Day 84
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Samples collected from subjects, after multiple topical ocular dosing of LHA510, were analyzed to determine concentrations of LHA510 and its metabolite, CRA398.
Plasma LHA510 and CRA398 concentrations were quantitated by a validated liquid chromatography-tandem mass spectroscopy assay method.
Below the limit of quantification (BLQ) is treated as zero.
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Day 28, Day 84
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Scientist, CA CSI, ID/Multi-TA, Novartis Institutes for BioMedical Research, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Pharmaceutical Solutions
- Ranibizumab
- Ophthalmic Solutions
- Acrizanib
Other Study ID Numbers
- LHA510-2201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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