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

Phase 2CompletedNCT01535950

Novartis Pharmaceuticals43 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neovascular Age-elated Macular Degeneration (Wet AMD)Exudative Macular Degeneration

Interventions

LFG316DRUG

PlaceboDRUG

Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (7)

Novartis Investigative Site

Tucson, Arizona, United States

Novartis Investigative Site

Torrance, California, United States

Novartis Investigative Site

Fort Myers, Florida, United States

Novartis Investigative Site

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time

Number or retreatments with anti-VEGF treatments will be recorded

Time frame: Day 1 to 113

Secondary Outcomes

The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.

Number or retreatments with anti-VEGF treatments will be recorded

Time frame: Day 1 and 113

Effect of LFG316 on visual acuity

Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded.

Time frame: Day 1 and 113

Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable

Summary statistics of these variables will be provided by treatment and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85.

Time frame: Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study)

Serum concentrations of total LFG316 versus time

Blood samples will be collected

Time frame: Days 1, 8, 15, 29, 43, 57, 71, 85 and 113

Number of patients with adverse events

Adverse events will be determined based on descriptive analyses of vital signs, electrocardiogram (ECG) evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.

Time frame: Day 113

Data from ClinicalTrials.gov

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