Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03295877 |
Recruitment Status :
Completed
First Posted : September 28, 2017
Last Update Posted : February 12, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Geographic Atrophy | Drug: RO7171009 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 21, 2017 |
Actual Primary Completion Date : | November 20, 2018 |
Actual Study Completion Date : | November 20, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: RO7171009: SAD
Patients will receive a single dose of RO7171009, in multiple escalating cohorts.
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Drug: RO7171009
Patients will receive RO7171009 via ITV injection. |
Experimental: RO7171009: MD
Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.
|
Drug: RO7171009
Patients will receive RO7171009 via ITV injection. |
- Safety and Tolerability of the Study Drug: Rate of Adverse Events [ Time Frame: Through study completion or early study discontinuation (overall 12-20 weeks) ]
- Serum Concentration of RO7171009 [ Time Frame: Through study completion or early study discontinuation (overall 12-20 weeks) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295877
United States, California | |
California Retina Consultants | |
Bakersfield, California, United States, 93309 | |
Northern California Retina Vitreous Associates | |
Mountain View, California, United States, 94040 | |
Retinal Consultants Med Group | |
Sacramento, California, United States, 95825 | |
California Retina Consultants | |
Santa Barbara, California, United States, 93103 | |
California Retina Consultants - Santa Maria | |
Santa Maria, California, United States, 93454 | |
United States, Colorado | |
Retina Consultants of Southern Colorado PC; Clinical Research Department | |
Colorado Springs, Colorado, United States, 80909-1183 | |
United States, Florida | |
Florida Eye Associates | |
Melbourne, Florida, United States, 32901 | |
Retina Specialty Institute | |
Pensacola, Florida, United States, 32503 | |
United States, Georgia | |
Georgia Retina PC | |
Marietta, Georgia, United States, 30060 | |
United States, Missouri | |
The Retina Institute | |
Saint Louis, Missouri, United States, 63128 | |
United States, Nevada | |
Sierra Eye Associates | |
Reno, Nevada, United States, 89502 | |
United States, North Carolina | |
Western Carolina Retinal Associate PA | |
Asheville, North Carolina, United States, 28803 | |
United States, Tennessee | |
Tennessee Retina PC. | |
Nashville, Tennessee, United States, 37203 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT03295877 |
Other Study ID Numbers: |
GR39821 |
First Posted: | September 28, 2017 Key Record Dates |
Last Update Posted: | February 12, 2020 |
Last Verified: | February 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Macular Degeneration Geographic Atrophy Atrophy Retinal Degeneration |
Retinal Diseases Eye Diseases Pathological Conditions, Anatomical |