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 |
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.
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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2770 North Union Boulevard
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
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