NCT03295877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

September 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

September 19, 2017

Last Update Submit

February 10, 2020

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability of the Study Drug: Rate of Adverse Events

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

Secondary Outcomes (1)

  • Serum Concentration of RO7171009

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

Study Arms (2)

RO7171009: SAD

EXPERIMENTAL

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

Drug: RO7171009

RO7171009: MD

EXPERIMENTAL

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

Drug: RO7171009

Interventions

RO7171009DRUG

Patients will receive RO7171009 via ITV injection.

RO7171009: MDRO7171009: SAD

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Retinal Consultants Med Group

Sacramento, California, 95825, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

California Retina Consultants - Santa Maria

Santa Maria, California, 93454, United States

Location

Retina Consultants of Southern Colorado PC; Clinical Research Department

Colorado Springs, Colorado, 80909-1183, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Georgia Retina PC

Marietta, Georgia, 30060, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803, United States

Location

Tennessee Retina PC.

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 28, 2017

Study Start

September 21, 2017

Primary Completion

November 20, 2018

Study Completion

November 20, 2018

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

US(13)