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

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

This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.

Study Overview

• Status: Completed
• Conditions: Exudative Macular Degeneration; Neovascular Age-elated Macular Degeneration (Wet AMD)
• Intervention / Treatment: Drug: LFG316; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704-5614
      • Novartis Investigative Site
  • California
    • Torrance, California, United States, 90503
      • Novartis Investigative Site
  • Florida
    • Fort Myers, Florida, United States, 33912-7125
      • Novartis Investigative Site
  • Maryland
    • Baltimore, Maryland, United States, 21237-4350
      • Novartis Investigative Site
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Novartis Investigative Site
  • Texas
    • Abilene, Texas, United States, 79606
      • Novartis Investigative Site
    • Fort Worth, Texas, United States, 76104
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham	Drug: Placebo; Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.
Experimental: LFG316	Drug: LFG316

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time	Number or retreatments with anti-VEGF treatments will be recorded	Day 1 to 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 and 113
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.	Day 1 and 113
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.	Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study)
Serum concentrations of total LFG316 versus time	Blood samples will be collected	Days 1, 8, 15, 29, 43, 57, 71, 85 and 113
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.	Day 113

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CLFG316A2202 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 20, 2012

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Age-related macular degeneration; Macular degeneration; Intravitreal; wet AMD; anti-vascular endothelial growth factor; Neovascular; intravitreal, neovascular; Age-related
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: CLFG316A2202