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Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

Primary Purpose

Advanced Age-related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LFG316
LFG316
LFG316
LFG316
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Age-related Macular Degeneration focused on measuring AMD,, ARMD,, Age-related Macular Degeneration,, Eye Disease,, Wet AMD,, Neovascular AMD,, Choroidal Neovascular Membrane,, Choroidal Neovascularization,, Drusen,, Geographic Atrophy,, Complement,, C5,, Antibody

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Retinal Consultants of Arizona,
  • Retina-Vitreous Associates Medical Group,
  • National Ophthalmic Research Institute
  • Center for Retina and Macular Disease
  • Opthalmic Consultants of Boston
  • Charlotte Eye, Ear, Nose and Throat Associates
  • Texas Retina Associates
  • Retina Consultants of Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

LFG316 0.15mg

LFG316 0.5mg

LFG316 1.5mg

LFG316 5mg

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.

Secondary Outcome Measures

To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.

Full Information

First Posted
December 6, 2010
Last Updated
April 30, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01255462
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LFG316 0.15mg
Arm Type
Experimental
Arm Title
LFG316 0.5mg
Arm Type
Experimental
Arm Title
LFG316 1.5mg
Arm Type
Experimental
Arm Title
LFG316 5mg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
LFG316
Intervention Type
Biological
Intervention Name(s)
LFG316
Intervention Type
Biological
Intervention Name(s)
LFG316
Intervention Type
Biological
Intervention Name(s)
LFG316
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona,
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group,
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Opthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

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