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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03295877

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

2.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

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 :

Sep 21, 2017

Actual Primary Completion Date :

Nov 20, 2018

Actual Study Completion Date :

Nov 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.

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

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

Serum Concentration of RO7171009 [Through study completion or early study discontinuation (overall 12-20 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	California Retina Consultants	Bakersfield	California	United States	93309
2	Northern California Retina Vitreous Associates	Mountain View	California	United States	94040
3	Retinal Consultants Med Group	Sacramento	California	United States	95825
4	California Retina Consultants	Santa Barbara	California	United States	93103
5	California Retina Consultants - Santa Maria	Santa Maria	California	United States	93454
6	Retina Consultants of Southern Colorado PC; Clinical Research Department	Colorado Springs	Colorado	United States	80909-1183
7	Florida Eye Associates	Melbourne	Florida	United States	32901
8	Retina Specialty Institute	Pensacola	Florida	United States	32503
9	Georgia Retina PC	Marietta	Georgia	United States	30060
10	The Retina Institute	Saint Louis	Missouri	United States	63128
11	Sierra Eye Associates	Reno	Nevada	United States	89502
12	Western Carolina Retinal Associate PA	Asheville	North Carolina	United States	28803
13	Tennessee Retina PC.	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

Genentech, Inc.

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genentech, Inc.

ClinicalTrials.gov Identifier:

NCT03295877

Other Study ID Numbers:

GR39821

First Posted:

Sep 28, 2017

Last Update Posted:

Feb 12, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Degeneration

Geographic Atrophy

Atrophy

Study Results

No Results Posted as of Feb 12, 2020