Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01255462

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Age-related Macular Degeneration	Biological: LFG316 Biological: LFG316 Biological: LFG316 Biological: LFG316	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LFG316 0.15mg	Biological: LFG316
Experimental: LFG316 0.5mg	Biological: LFG316
Experimental: LFG316 1.5mg	Biological: LFG316
Experimental: LFG316 5mg	Biological: LFG316

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. [Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)]

Secondary Outcome Measures

To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. [Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retinal Consultants of Arizona,	Phoenix	Arizona	United States	85014
2	Retina-Vitreous Associates Medical Group,	Beverly Hills	California	United States	90211
3	National Ophthalmic Research Institute	Fort Myers	Florida	United States	33912
4	Center for Retina and Macular Disease	Winter Haven	Florida	United States	33880
5	Opthalmic Consultants of Boston	Boston	Massachusetts	United States	02114
6	Charlotte Eye, Ear, Nose and Throat Associates	Charlotte	North Carolina	United States	28210
7	Texas Retina Associates	Dallas	Texas	United States	75231
8	Retina Consultants of Houston	Houston	Texas	United States	77030