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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01535950

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-elated Macular Degeneration (Wet AMD) Exudative Macular Degeneration	Drug: LFG316 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LFG316	Drug: LFG316
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.

Arm

Intervention/Treatment

Experimental: LFG316

Drug: LFG316

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.

Outcome Measures

Primary Outcome Measures

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

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
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.
Serum concentrations of total LFG316 versus time [Days 1, 8, 15, 29, 43, 57, 71, 85 and 113]
Blood samples will be collected
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Tucson	Arizona	United States	85704-5614
2	Novartis Investigative Site	Torrance	California	United States	90503
3	Novartis Investigative Site	Fort Myers	Florida	United States	33912-7125
4	Novartis Investigative Site	Baltimore	Maryland	United States	21237-4350
5	Novartis Investigative Site	West Columbia	South Carolina	United States	29169
6	Novartis Investigative Site	Abilene	Texas	United States	79606
7	Novartis Investigative Site	Fort Worth	Texas	United States	76104