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LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT02355028
Recruitment Status : Completed
First Posted : February 4, 2015
Results First Posted : November 14, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of 84 successive days of topically administered LHA510 compared to vehicle in reducing the number of patients requiring intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis®) for recurrence of active choroidal neovascularization (CNV).

Condition or disease Intervention/treatment Phase
Exudative Age-Related Macular Degeneration Drug: LHA510 ophthalmic suspension Drug: LHA510 vehicle Drug: Ranibizumab ophthalmic solution Phase 2

Detailed Description:
On Day -1, patients will receive an IVT Lucentis® injection in the study eye, and then will be randomized to receive either topical LHA510 ophthalmic suspension or vehicle in a 1:1 ratio for 84 days. Patients with recurrence of active CNV in the study eye during the study will receive rescue IVT Lucentis® injections. Following the treatment period, subjects will return for a follow-up visit and a disposition visit. Only one eye (designated as the study eye) will be dosed with either topical LHA510 or vehicle per patient.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 3, 2015
Actual Primary Completion Date : September 15, 2016
Actual Study Completion Date : October 18, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: LHA510 ophthalmic suspension
Drug: Ranibizumab ophthalmic solution
For intravitreal (IVT) injection
Other Name: Lucentis®
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.
 Drug: LHA510 vehicle
Inactive ingredients used as a placebo comparator

Drug: Ranibizumab ophthalmic solution
For intravitreal (IVT) injection
Other Name: Lucentis®


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84 [ Time Frame: Day 84 ]
    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.


Secondary Outcome Measures :
  1. Time to First LUCENTIS® Retreatment Need Identification up to Day 84 [ Time Frame: Day 14, Day 28, Day 56, Day 84 ]
    The time was determined based on the visit of the treatment period when a patient was identified as requiring retreatment with LUCENTIS.

  2. Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84 [ Time Frame: Up to Day 84 ]
    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

  3. Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56 [ Time Frame: Day 28, Day 56 ]
    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.

  4. 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 ]
    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.

  5. 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 ]
    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.

  6. Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit [ Time Frame: Day -1, Day 28, Day 84 ]
    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.

  7. Change From Randomization Visit (Day -1) in Lesion Thickness by Visit [ Time Frame: Day -1, Day 28, Day 84 ]
    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.

  8. Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit [ Time Frame: Day -1, Day 28, Day 84 ]
    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.

  9. Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit [ Time Frame: Day -1, Day 28, Day 84 ]
    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.

  10. Change From Randomization Visit (Day -1) in Total Lesion Size by Visit [ Time Frame: Day -1, Day 84 ]
    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.

  11. Change From Randomization Visit (Day -1) in CNV Size by Visit [ Time Frame: Day -1, Day 84 ]
    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.

  12. Plasma Concentration of LHA510 and CRA398 [ Time Frame: Day 28, Day 84 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355028


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon, a Novartis Company
Investigators
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Study Director: Clinical Scientist, CA CSI, ID/Multi-TA Novartis Institutes for BioMedical Research, Inc.
More Information
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Responsible Party: Alcon, a Novartis Company
ClinicalTrials.gov Identifier: NCT02355028    
Other Study ID Numbers: LHA510-2201
First Posted: February 4, 2015    Key Record Dates
Results First Posted: November 14, 2017
Last Update Posted: July 2, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.
Keywords provided by Alcon Research ( Alcon, a Novartis Company ):
LHA510
PoC
Age-related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Ophthalmic Solutions
Acrizanib
Pharmaceutical Solutions
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action