Back to resultsSafety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Primary Purpose
Geographic Atrophy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RO7171009
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy
Eligibility 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
Sites / Locations
- California Retina Consultants
- Northern California Retina Vitreous Associates
- Retinal Consultants Med Group
- California Retina Consultants
- California Retina Consultants - Santa Maria
- Retina Consultants of Southern Colorado PC; Clinical Research Department
- Florida Eye Associates
- Retina Specialty Institute
- Georgia Retina PC
- The Retina Institute
- Sierra Eye Associates
- Western Carolina Retinal Associate PA
- Tennessee Retina PC.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RO7171009: SAD
RO7171009: MD
Arm Description
Patients will receive a single dose of RO7171009, in multiple escalating cohorts.
Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.
Outcomes
Primary Outcome Measures
Safety and Tolerability of the Study Drug: Rate of Adverse Events
Secondary Outcome Measures
Serum Concentration of RO7171009
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03295877
Brief Title
Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RO7171009: SAD
Arm Type
Experimental
Arm Description
Patients will receive a single dose of RO7171009, in multiple escalating cohorts.
Arm Title
RO7171009: MD
Arm Type
Experimental
Arm Description
Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.
Intervention Type
Drug
Intervention Name(s)
RO7171009
Intervention Description
Patients will receive RO7171009 via ITV injection.
Primary Outcome Measure Information:
Title
Safety and Tolerability of the Study Drug: Rate of Adverse Events
Time Frame
Through study completion or early study discontinuation (overall 12-20 weeks)
Secondary Outcome Measure Information:
Title
Serum Concentration of RO7171009
Time Frame
Through study completion or early study discontinuation (overall 12-20 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retinal Consultants Med Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
California Retina Consultants - Santa Maria
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Retina Consultants of Southern Colorado PC; Clinical Research Department
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909-1183
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Georgia Retina PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Western Carolina Retinal Associate PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Tennessee Retina PC.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
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