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

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ClinicalTrials.gov Identifier: NCT03295877
Recruitment Status : Active, not recruiting
First Posted : September 28, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Drug: RO7171009 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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
Estimated Primary Completion Date : October 24, 2018
Estimated Study Completion Date : October 24, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: RO7171009: SAD
Patients will receive a single dose of RO7171009, in multiple escalating cohorts.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Serum Concentration of RO7171009 [ Time Frame: Through study completion or early study discontinuation (overall 12-20 weeks) ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, California
California Retina Consultants
Bakersfield, California, United States, 93309
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
San Diego Retina Associates
Oceanside, California, United States, 92056
Retinal Consultants Med Group
Sacramento, California, United States, 95841
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, Iowa
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
United States, Missouri
The Retina Institute - Chesterfield
Chesterfield, Missouri, United States, 63017
The Retina Institute
Saint Louis, Missouri, United States, 63144
United States, Nevada
Sierra Eye Associates
Reno, Nevada, United States, 89502
United States, North Carolina
West Carolina Retinal AssocPA
Asheville, North Carolina, United States, 28803
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Tennessee Retina PC.
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03295877     History of Changes
Other Study ID Numbers: GR39821
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical