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A study to look at how safe a study medicine was for patients – when taken at different doses - and how this medicine was processed through the body
Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
- Age-Related Macular Degeneration
Trial Status:
Completed
This trial runs in
Cities
- Asheville
- Bakersfield
- Colorado Springs
- Marietta
- Melbourne
- Mountain View
- Nashville
- Pensacola
- Reno
- Sacramento
- Santa Barbara
- Santa Maria
- St. Louis
Trial Identifier:
NCT03295877 GR39821
Trial 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.
Genentech, Inc.
Sponsor
Phase 1
Phase
NCT03295877 , GR39821
Trial Identifier
All
Gender
≥ 50 Years
Age
No
Healthy Volunteers
This was a study to investigate a new medicine (FHTR2163) in patients with an eye disease, called “age-related macular degeneration with geographic atrophy”, or “AMD with GA”. Patients were injected in their eye with different amounts of the study medicine to find the dose that was safe.
Trial 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.
Genentech, Inc.
Sponsor
Phase 1
Phase
NCT03295877 , GR39821
Trial Identifier
RO7171009
Treatments
Geographic Atrophy
Condition
Official Title
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
Eligibility Criteria
All
Gender
≥ 50 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com