Overview

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

Status:
Completed
Trial end date:
2018-11-20
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Criteria
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