Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

NCT01255462 | Completed Phase 1

• 1 other identifier: CLFG316A2102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

Brief Summary

This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.

Conditions

Advanced Age-related Macular Degeneration

Keywords

AMD,; ARMD,; Age-related Macular Degeneration,; Eye Disease,; Wet AMD,; Neovascular AMD,; Choroidal Neovascular Membrane,; Choroidal Neovascularization,; Drusen,; Geographic Atrophy,; Complement,; C5,; Antibody

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.

  Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)

Secondary Outcomes (1)

• To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.

  Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)

Study Arms (4)

LFG316 0.15mg

EXPERIMENTAL

Biological: LFG316

LFG316 0.5mg

EXPERIMENTAL

Biological: LFG316

LFG316 1.5mg

EXPERIMENTAL

Biological: LFG316

LFG316 5mg

EXPERIMENTAL

Biological: LFG316

Interventions

LFG316 BIOLOGICAL

LFG316 0.15mg

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female AMD patients 55 to 90 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
• ETDRS best corrected visual acuity of 60 letters or worse in the study eye.

You may not qualify if:

• Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
• Choroidal neovascularization due to a cause other than AMD.
• In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
• Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
• Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.
• Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye.
• Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation.
• Any medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Retinal Consultants of Arizona,

Phoenix, Arizona, 85014, United States

Location

Retina-Vitreous Associates Medical Group,

Beverly Hills, California, 90211, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Opthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Charlotte Eye, Ear, Nose and Throat Associates

Charlotte, North Carolina, 28210, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Eye Diseases; Choroidal Neovascularization; Geographic Atrophy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

US (8)