CClinicalTrials.gg
CompletedNCT03295877Updated Feb 12, 2020

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

A Phase 1 interventional study of RO7171009 in Geographic Atrophy, sponsored by Genentech, Inc.. Completed at 13 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.

Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    RO7171009: SAD

    Patients will receive a single dose of RO7171009, in multiple escalating cohorts.

    Drug: RO7171009

  • Experimental
    RO7171009: MD

    Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.

    Drug: RO7171009

Interventions

  • DrugRO7171009

    Patients will receive RO7171009 via ITV injection.

05

What researchers measure

Primary outcomes

  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 outcomes

  1. Serum Concentration of RO7171009

    Time frame: Through study completion or early study discontinuation (overall 12-20 weeks)

06

Study locations

13 sites
  • California Retina Consultants
    Bakersfield, California 93309, United States
  • Northern California Retina Vitreous Associates
    Mountain View, California 94040, United States
  • Retinal Consultants Med Group
    Sacramento, California 95825, United States
  • California Retina Consultants
    Santa Barbara, California 93103, United States
  • California Retina Consultants - Santa Maria
    Santa Maria, California 93454, United States
  • Retina Consultants of Southern Colorado PC; Clinical Research Department
    Colorado Springs, Colorado 80909-1183, United States
  • Florida Eye Associates
    Melbourne, Florida 32901, United States
  • Retina Specialty Institute
    Pensacola, Florida 32503, United States
  • Georgia Retina PC
    Marietta, Georgia 30060, United States
  • The Retina Institute
    Saint Louis, Missouri 63128, United States
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
  • Western Carolina Retinal Associate PA
    Asheville, North Carolina 28803, United States
  • Tennessee Retina PC.
    Nashville, Tennessee 37203, United States
07

Registry details

Key details

Study ID
NCT03295877
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Sep 21, 2017
Primary completion
Nov 20, 2018
Completion
Nov 20, 2018
Last update
Feb 12, 2020

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion