Clinical trial NCT01255462: Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
Official title: A Multicenter, Open Label, Single Ascending Dose Study to Assess the Safety, Tolerability, and Serum Pharmacokinetics of Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Age-related Macular Degeneration
Keywords: AMD,
ARMD,
Age-related Macular Degeneration,
Eye Disease,
Wet AMD,
Neovascular AMD,
Choroidal Neovascular Membrane,
Choroidal Neovascularization,
Drusen,
Geographic Atrophy,
Complement,
C5,
Antibody
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-07
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Male or female AMD patients 55 to 90 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
* ETDRS best corrected visual acuity of 60 letters or worse in the study eye.

Exclusion Criteria:

* Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
* Choroidal neovascularization due to a cause other than AMD.
* In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
* Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
* Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.
* Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye.
* Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation.
* Any medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
timeFrame: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
Secondary outcomes:
measure: To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
timeFrame: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona,
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group,
state: California
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Boston
country: United States
facility: Opthalmic Consultants of Boston
state: Massachusetts
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose and Throat Associates
state: North Carolina
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: