Expired Study
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Fort Worth, Texas 76134


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).


Study summary:

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.


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.


NCT ID:

NCT02355028


Primary Contact:

Study Director
Clinical Scientist, CA CSI, ID/Multi-TA
Novartis Institutes for BioMedical Research, Inc.


Backup Contact:

N/A


Location Contact:

Fort Worth, Texas 76134
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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