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
sites
2770 North Union Boulevard
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials