Clinical trial NCT02355028: LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Exudative Age-Related Macular Degeneration
Keywords: LHA510
PoC
Age-related macular degeneration
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-02-04
Enrollment: 136
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84
timeFrame: Day 84
Secondary outcomes:
measure: Time to First LUCENTIS® Retreatment Need Identification up to Day 84
timeFrame: Day 14, Day 28, Day 56, Day 84
measure: Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84
timeFrame: Up to Day 84
measure: Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56
timeFrame: Day 28, Day 56
measure: Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site
timeFrame: Day -1, Day 14, Day 28, Day 56, Day 84
measure: Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site
timeFrame: Day -1, Day 14, Day 28, Day 56, Day 84
measure: Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit
timeFrame: Day -1, Day 28, Day 84
measure: Change From Randomization Visit (Day -1) in Lesion Thickness by Visit
timeFrame: Day -1, Day 28, Day 84
measure: Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit
timeFrame: Day -1, Day 28, Day 84
measure: Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit
timeFrame: Day -1, Day 28, Day 84
measure: Change From Randomization Visit (Day -1) in Total Lesion Size by Visit
timeFrame: Day -1, Day 84
measure: Change From Randomization Visit (Day -1) in CNV Size by Visit
timeFrame: Day -1, Day 84
measure: Plasma Concentration of LHA510 and CRA398
timeFrame: Day 28, Day 84
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Novartis Institutes for BioMedical Research, Inc.
name: Clinical Scientist, CA CSI, ID/Multi-TA
role: STUDY_DIRECTOR
References: