Overview

This trial has been completed.

Condition exudative age-related macular degeneration
Treatments lha510 ophthalmic suspension, lha510 vehicle, ranibizumab ophthalmic solution
Phase phase 2
Sponsor Alcon, a Novartis Company
Start date March 2015
End date October 2016
Trial size 135 participants
Trial identifier NCT02355028, LHA510-2201

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
lha510 ophthalmic suspension
ranibizumab ophthalmic solution Lucentis®
For intravitreal (IVT) injection
(Placebo Comparator)
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.
lha510 vehicle
Inactive ingredients used as a placebo comparator
ranibizumab ophthalmic solution Lucentis®
For intravitreal (IVT) injection

Primary Outcomes

Measure
Number of patients requiring Lucentis® retreatment before or at Day 84
time frame: Day 84

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 50 years up to 90 years old.

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.

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Alcon Research.