NCT01535950

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 19, 2020

Status Verified

March 1, 2016

Enrollment Period

1.4 years

First QC Date

February 10, 2012

Last Update Submit

December 11, 2020

Conditions

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

Keywords

Age-related macular degenerationintravitreal, neovascularanti-vascular endothelial growth factorwet AMDAge-relatedMacular degenerationIntravitrealNeovascular

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.

    Day 1 and 113

  • Effect of LFG316 on visual acuity

    Day 1 and 113

  • Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable

    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

    Days 1, 8, 15, 29, 43, 57, 71, 85 and 113

  • Number of patients with adverse events

    Day 113

Study Arms (2)

LFG316

EXPERIMENTAL
Drug: LFG316

Sham

SHAM COMPARATOR
Drug: Placebo

Interventions

LFG316DRUG
LFG316
PlaceboDRUG

Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.

Sham

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • History of recurrent non-response to anti-VEGF therapy in the study eye.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Novartis Investigative Site

Tucson, Arizona, 85704-5614, United States

Location

Novartis Investigative Site

Torrance, California, 90503, United States

Location

Novartis Investigative Site

Fort Myers, Florida, 33912-7125, United States

Location

Novartis Investigative Site

Baltimore, Maryland, 21237-4350, United States

Location

Novartis Investigative Site

West Columbia, South Carolina, 29169, United States

Location

Novartis Investigative Site

Abilene, Texas, 79606, United States

Location

Novartis Investigative Site

Fort Worth, Texas, 76104, United States

Location

Related Links

MeSH Terms

Conditions

Wet Macular DegenerationMacular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 20, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 19, 2020

Record last verified: 2016-03

Locations

US(7)