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

Completed · Phase 1

Conditions studied: Geographic Atrophy

In brief

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.

Key facts

Study ID

NCT03295877

Run by

Genentech, Inc.

People needed

28

Starts

2017-09-21

Expected to finish

2018-11-20

Last updated by the study team

2020-02-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Retina Consultants — Bakersfield, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• Retinal Consultants Med Group — Sacramento, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• California Retina Consultants - Santa Maria — Santa Maria, California, United States
• Retina Consultants of Southern Colorado PC; Clinical Research Department — Colorado Springs, Colorado, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Georgia Retina PC — Marietta, Georgia, United States
• The Retina Institute — St Louis, Missouri, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Western Carolina Retinal Associate PA — Asheville, North Carolina, United States
• Tennessee Retina PC. — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.