Clinical trial NCT01535950: Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
Official title: A Multicenter, Randomized, Sham-controlled, Repeat-dose Study to Assess the Safety, Tolerability, Serum Pharmacokinetics, and Efficacy of Intravitreal LFG316 in Patients With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-elated Macular Degeneration (Wet AMD)
Exudative Macular Degeneration
Keywords: Age-related macular degeneration
intravitreal, neovascular
anti-vascular endothelial growth factor
wet AMD
Age-related
Macular degeneration
Intravitreal
Neovascular
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-02-20
Enrollment: 43
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time
timeFrame: Day 1 to 113
Secondary outcomes:
measure: The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.
timeFrame: Day 1 and 113
measure: Effect of LFG316 on visual acuity
timeFrame: Day 1 and 113
measure: Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable
timeFrame: Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study)
measure: Serum concentrations of total LFG316 versus time
timeFrame: Days 1, 8, 15, 29, 43, 57, 71, 85 and 113
measure: Number of patients with adverse events
timeFrame: Day 113
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Torrance
country: United States
facility: Novartis Investigative Site
state: California
city: Fort Myers
country: United States
facility: Novartis Investigative Site
state: Florida
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: West Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Abilene
country: United States
facility: Novartis Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: