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

Alcon

Status and phase: Completed; Phase 2

Conditions: Exudative Age-Related Macular Degeneration

Treatments: Drug: LHA510 ophthalmic suspension; Drug: LHA510 vehicle; Drug: Ranibizumab ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02355028

LHA510-2201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 2 patient groups, including a placebo group

LHA510

Experimental group

Description:

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.

Treatment:

Drug: LHA510 ophthalmic suspension

Drug: Ranibizumab ophthalmic solution

Vehicle

Placebo Comparator group

Description:

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.

Treatment:

Drug: LHA510 vehicle

Drug: Ranibizumab ophthalmic solution