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

Phase 2

Completed

• Conditions: Neovascular Age-elated Macular Degeneration (Wet AMD); Exudative Macular Degeneration
• Interventions: Drug: Placebo; Drug: LFG316

• Registration Number: NCT01535950
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-20
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-03
• Disposition First Submitted: 2016-03-22
• Disposition First Submitted QC: 2016-03-22
• Disposition First Posted: 2016-04-25
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Placebo	-
LFG316	LFG316	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of LFG316 on visual acuity	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.
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)	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.
The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.	Day 1 and 113	Number or retreatments with anti-VEGF treatments will be recorded
Number of patients with adverse events	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.
Serum concentrations of total LFG316 versus time	Days 1, 8, 15, 29, 43, 57, 71, 85 and 113	Blood samples will be collected

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Fort Worth, Texas, United States