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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Alcon, a Novartis Company · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Exudative Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	LHA510 ophthalmic suspension
DRUG	LHA510 vehicle	Inactive ingredients used as a placebo comparator
DRUG	Ranibizumab ophthalmic solution	For intravitreal (IVT) injection

Timeline

• Start date: 2015-03-03
• Primary completion: 2016-09-15
• Completion: 2016-10-18
• First posted: 2015-02-04
• Last updated: 2018-07-02
• Results posted: 2017-11-14

Locations

1 site across 1 country: United States