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

Exudative Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535950
• Other study ID #: CLFG316A2202
• Status: Completed
• Phase: Phase 2
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• LFG316

• 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.

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Abilene	Texas
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Fort Worth	Texas
United States	Novartis Investigative Site	Torrance	California
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	Serum concentrations of total LFG316 versus time	Blood samples will be collected	Days 1, 8, 15, 29, 43, 57, 71, 85 and 113
Secondary	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

External Links

•   Results for CLFG316A2202 from the Novartis Clinical Trials website