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

• ClinicalTrials.gov Identifier: NCT03295877
• Recruitment Status: Completed
• First Posted: September 28, 2017
• Last Update Posted: February 15, 2019
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

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.

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

Study Design

• 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

Arms and Interventions

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

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

• 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

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

Western Carolina Retinal Associate PA

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

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT03295877 History of Changes
• Other Study ID Numbers: GR39821
• First Posted: September 28, 2017
• Last Update Posted: February 15, 2019
• Last Verified: February 2019

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

Additional relevant MeSH terms:

Macular Degeneration; Geographic Atrophy; Atrophy; Retinal Degeneration; Retinal Diseases; Eye Diseases; Pathological Conditions, Anatomical