Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:2/17/2019
Start Date:September 21, 2017
End Date:November 20, 2018

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A Phase I, Multicenter, Open-Label, Single-Dose, Dose-Escalation, and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7171009 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

This Phase 1, open-label, multicenter study will investigate the safety and tolerability of
RO7171009 following single and multiple intravitreal (ITV) administrations in patients with
GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and
Multiple-Dose (MD) stages.


Inclusion Criteria:

- Participants aged greater than or equal to (>/=) 50 years

- Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active
choroidal neovascularization (CNV) in study eye

Exclusion Criteria:

Ocular Exclusion Criteria, Study Eye:

- History of vitrectomy surgery, submacular surgery, or other surgical intervention for
AMD

- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
occlusion, or proliferative diabetic retinopathy

- Prior treatment with Visudyne®, external beam radiation therapy (for intraocular
conditions), or transpupillary thermotherapy

Ocular Exclusion Criteria (Both Eyes):

- GA in either eye due to causes other than AMD

- Evidence of prior or active CNV

- Previous participation in interventional clinical trials for GA or dry AMD, except for
vitamins and minerals, irrespective of the route of administration (i.e., ocular or
systemic) within the last 6 months
We found this trial at
17
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Nashville, Tennessee 37203
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Asheville, North Carolina 28803
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Bakersfield, California 93309
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Bakersfield, CA
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226 South Woods Mill Road
Chesterfield, Missouri 63017
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Chesterfield, MO
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Cincinnati, Ohio 45242
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Cincinnati, OH
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2770 North Union Boulevard
Colorado Springs, Colorado 80909
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Colorado Springs, CO
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Marietta, Georgia 30060
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Marietta, GA
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502 East New Haven Avenue
Melbourne, Florida 32901
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Melbourne, FL
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Mountain View, California 94040
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Mountain View, CA
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Oceanside, California 92056
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Oceanside, CA
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Pensacola, Florida 32503
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Reno, Nevada 89502
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Reno, NV
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Sacramento, California 95819
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Sacramento, CA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Santa Barbara, California 93103
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Santa Barbara, CA
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1510 East Main Street
Santa Maria, California 93454
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Santa Maria, CA
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West Des Moines, Iowa 50266
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West Des Moines, IA
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