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).
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.
- 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
- 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.
- 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
- Other protocol-specified exclusion criteria may apply.
Clinical Scientist, CA CSI, ID/Multi-TA
Novartis Institutes for BioMedical Research, Inc.