This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )
ClinicalTrials.gov Identifier:
NCT02355028
First received: January 28, 2015
Last updated: January 9, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Exudative Age-Related Macular Degeneration Drug: LHA510 ophthalmic suspension Drug: LHA510 vehicle Drug: Ranibizumab ophthalmic solution Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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)

Resource links provided by NLM:


Further study details as provided by Alcon Research ( Alcon, a Novartis Company ):

Primary Outcome Measures:
  • Number of patients requiring Lucentis® retreatment before or at Day 84 [ Time Frame: Day 84 ]

Secondary Outcome Measures:
  • Time to first injection of Lucentis® required up to Day 84 [ Time Frame: Up to Day 84 ]
  • Number of Lucentis® injections required up to Day 84 [ Time Frame: Day 84 ]
  • Change from Randomization Visit (Day -1) in central subfield thickness total (CSFTtot) at each visit [ Time Frame: Day -1, Up to Day 84 ]
  • Change from Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at each visit [ Time Frame: Day -1, Up to Day 84 ]
  • Change from Randomization Visit (Day -1) in central subfield thickness, neuro retina (CSFTnr) at each visit [ Time Frame: Day -1, Up to Day 84 ]
  • Change from Randomization Visit (Day -1) in lesion thickness at each visit [ Time Frame: Day -1, Up to Day 84 ]
  • Change from Randomization Visit (Day -1) in subretinal fluid - foveal involvement (SRFfi) thickness at each visit [ Time Frame: Day -1, Up to Day 84 ]
  • Change from Randomization Visit (Day -1) in pigment epithelial detachment - foveal involvement (PEDfi) thickness at each visit [ Time Frame: Day -1, Up to Day 84 ]
  • Change from Randomization Visit (Day -1) in total lesion size at each visit [ Time Frame: Day -1, Up to Day 84 ]
  • Change from Randomization Visit (Day -1) in CNV size at each visit [ Time Frame: Day -1, Up to Day 84 ]
  • The observed maximum plasma (or serum or blood) concentration following drug administration [mass / volume] (Cmax) [ Time Frame: Day 28, Day 84 ]
    Contingent upon observed serum concentration levels


Enrollment: 135
Study Start Date: March 2015
Study Completion Date: October 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 standard of care.
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 standard of care.
Drug: LHA510 vehicle
Inactive ingredients used as a placebo comparator
Drug: Ranibizumab ophthalmic solution
For intravitreal (IVT) injection
Other Name: Lucentis®

Detailed Description:
The standard of care for recurrence of active CNV is an IVT injection of an anti-VEGF agent. In this study, recurrence of CNV will be treated exclusively with IVT Lucentis®. On Day -1, patients will receive an IVT Lucentis® injection, and then will be randomized to receive either topical LHA510 ophthalmic suspension or vehicle in a 1:1 ratio.
  Eligibility

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

Inclusion Criteria:

  • Sign written informed consent form;
  • Wet AMD patient;
  • 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 (patient or care-giver);
  • CNV recently demonstrated high need for frequent anti-VEGF therapy and sustained functional and clear anatomical response 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02355028

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon, a Novartis Company
Investigators
Study Director: Clinical Scientist, CA CSI, ID/Multi-TA Novartis Institutes for BioMedical Research, Inc.
  More Information

Responsible Party: Alcon, a Novartis Company
ClinicalTrials.gov Identifier: NCT02355028     History of Changes
Other Study ID Numbers: LHA510-2201
Study First Received: January 28, 2015
Last Updated: January 9, 2017

Keywords provided by Alcon Research ( Alcon, a Novartis Company ):
LHA510
PoC
Age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions
Ranibizumab
Ophthalmic Solutions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017