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Completed

NCT Number: NCT01535950

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

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

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Key information

Conditions

Neovascular Age-elated Macular Degeneration (Wet AMD) Exudative Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Wet Macular Degeneration

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LFG316

Drug

Placebo

Drug

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 outcomes

  1. Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time

    Time frame: Day 1 to 113

    Number or retreatments with anti-VEGF treatments will be recorded

Secondary outcomes

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

    Time frame: Day 1 and 113

    Number or retreatments with anti-VEGF treatments will be recorded

  2. Effect of LFG316 on visual acuity

    Time frame: Day 1 and 113

    Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded.

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

    Time frame: Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study)

    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.

  4. Serum concentrations of total LFG316 versus time

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

    Blood samples will be collected

  5. Number of patients with adverse events

    Time frame: Day 113

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2012
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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