Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01255462

First received: December 6, 2010

Last updated: April 30, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 6, 2010

Last Updated Date

April 30, 2012

Start Date ^ICMJE

November 2010

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01255462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. [ Time Frame: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Advanced Age-related Macular Degeneration

Intervention ^ICMJE

Biological: LFG316

Study Arm (s)

Experimental: LFG316 0.15mg
Intervention: Biological: LFG316
Experimental: LFG316 0.5mg
Intervention: Biological: LFG316
Experimental: LFG316 1.5mg
Intervention: Biological: LFG316
Experimental: LFG316 5mg
Intervention: Biological: LFG316

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

55 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01255462

Other Study ID Numbers ^ICMJE

CLFG316A2102

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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