Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)

Novartis

Status and phase

Completed

Phase 2

Conditions

Exudative Macular Degeneration

Neovascular Age-elated Macular Degeneration (Wet AMD)

Treatments

Drug: LFG316

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

CLFG316A2202

Details and patient eligibility

About

This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.

Enrollment

43 patients

Sex

All

Ages

55 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye.
An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye.
History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye.

Exclusion criteria

History of recurrent non-response to anti-VEGF therapy in the study eye.
In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary).
Choroidal neovascularization due to a cause other than AMD.
In the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study.
History of infectious uveitis or endophthalmitis in either eye.
Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other VEGF inhibitor.
Any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye