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

NCT ID: NCT02355028

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-03
• Study Completion Date: 2016-10-18

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.

Conditions

Exudative Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 as standard of care rescue therapy.

Group Type: EXPERIMENTAL

LHA510 ophthalmic suspension

Intervention Type: DRUG

Ranibizumab ophthalmic solution

Intervention Type: DRUG

For intravitreal (IVT) injection

Vehicle

LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.

Group Type: PLACEBO_COMPARATOR

LHA510 vehicle

Intervention Type: DRUG

Inactive ingredients used as a placebo comparator

Ranibizumab ophthalmic solution

Intervention Type: DRUG

For intravitreal (IVT) injection

Interventions

LHA510 ophthalmic suspension

Intervention Type: DRUG

LHA510 vehicle

Inactive ingredients used as a placebo comparator

Intervention Type: DRUG

Ranibizumab ophthalmic solution

For intravitreal (IVT) injection

Intervention Type: DRUG

Other Intervention Names

Lucentis®

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;

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;

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon, a Novartis Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Scientist, CA CSI, ID/Multi-TA

Role: STUDY_DIRECTOR

Novartis Institutes for BioMedical Research, Inc.

Locations

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

LHA510-2201

Identifier Type: -

Identifier Source: org_study_id