Overview

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

Status:
Completed
Trial end date:
2016-10-18
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon, a Novartis Company
Treatments:
Acrizanib
Ophthalmic Solutions
Pharmaceutical Solutions
Ranibizumab
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.