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

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

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.

Study Overview

• Status: Completed
• Conditions: Geographic Atrophy
• Intervention / Treatment: Drug: RO7171009

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Consultants
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates
    • Sacramento, California, United States, 95825
      • Retinal Consultants Med Group
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
    • Santa Maria, California, United States, 93454
      • California Retina Consultants - Santa Maria
  • Colorado
    • Colorado Springs, Colorado, United States, 80909-1183
      • Retina Consultants of Southern Colorado PC; Clinical Research Department
  • Florida
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Georgia Retina PC
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • The Retina Institute
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Retinal Associate PA
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina PC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability of the Study Drug: Rate of Adverse Events	Through study completion or early study discontinuation (overall 12-20 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum Concentration of RO7171009	Through study completion or early study discontinuation (overall 12-20 weeks)

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Actual): November 20, 2018
• Study Completion (Actual): November 20, 2018

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Macular Degeneration; Geographic Atrophy; Atrophy
• Other Study ID Numbers: GR39821

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No