Status:
COMPLETED
Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Lead Sponsor:
Genentech, Inc.
Conditions:
Geographic Atrophy
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03295877
Start Date
September 21 2017
End Date
November 20 2018
Last Update
February 12 2020
Active Locations (13)
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1
California Retina Consultants
Bakersfield, California, United States, 93309
2
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
3
Retinal Consultants Med Group
Sacramento, California, United States, 95825
4
California Retina Consultants
Santa Barbara, California, United States, 93103