Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Age-related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LFG316 0.15mg

Group Type EXPERIMENTAL

LFG316

Intervention Type BIOLOGICAL

LFG316 0.5mg

Group Type EXPERIMENTAL

LFG316

Intervention Type BIOLOGICAL

LFG316 1.5mg

Group Type EXPERIMENTAL

LFG316

Intervention Type BIOLOGICAL

LFG316 5mg

Group Type EXPERIMENTAL

LFG316

Intervention Type BIOLOGICAL

Interventions

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LFG316

Intervention Type BIOLOGICAL

LFG316

Intervention Type BIOLOGICAL

LFG316

Intervention Type BIOLOGICAL

LFG316

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No