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Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)

Primary Purpose

Neovascular Age-elated Macular Degeneration (Wet AMD), Exudative Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LFG316
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-elated Macular Degeneration (Wet AMD) focused on measuring Age-related macular degeneration, intravitreal, neovascular, anti-vascular endothelial growth factor, wet AMD, Age-related, Macular degeneration, Intravitreal, Neovascular

Eligibility Criteria

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

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

LFG316

Sham

Arm Description

Outcomes

Primary Outcome Measures

Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time
Number or retreatments with anti-VEGF treatments will be recorded

Secondary Outcome Measures

The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.
Number or retreatments with anti-VEGF treatments will be recorded
Effect of LFG316 on visual acuity
Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded.
Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable
Summary statistics of these variables will be provided by treatment and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85.
Serum concentrations of total LFG316 versus time
Blood samples will be collected
Number of patients with adverse events
Adverse events will be determined based on descriptive analyses of vital signs, electrocardiogram (ECG) evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.

Full Information

First Posted
February 10, 2012
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01535950
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (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 and efficacy of LFG316 in patients with age related macular degeneration.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LFG316
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
LFG316
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.
Primary Outcome Measure Information:
Title
Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time
Description
Number or retreatments with anti-VEGF treatments will be recorded
Time Frame
Day 1 to 113
Secondary Outcome Measure Information:
Title
The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.
Description
Number or retreatments with anti-VEGF treatments will be recorded
Time Frame
Day 1 and 113
Title
Effect of LFG316 on visual acuity
Description
Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded.
Time Frame
Day 1 and 113
Title
Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable
Description
Summary statistics of these variables will be provided by treatment and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85.
Time Frame
Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study)
Title
Serum concentrations of total LFG316 versus time
Description
Blood samples will be collected
Time Frame
Days 1, 8, 15, 29, 43, 57, 71, 85 and 113
Title
Number of patients with adverse events
Description
Adverse events will be determined based on descriptive analyses of vital signs, electrocardiogram (ECG) evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.
Time Frame
Day 113

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: 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
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
Novartis Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704-5614
Country
United States
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912-7125
Country
United States
Facility Name
Novartis Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237-4350
Country
United States
Facility Name
Novartis Investigative Site
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Novartis Investigative Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12244
Description
Results for CLFG316A2202 from the Novartis Clinical Trials website

Learn more about this trial

Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)

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