A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy

November 1, 2016 updated by: Genentech, Inc.

A Phase Ib/II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Intravitreal Injections Administered Monthly or Every Other Month to Patients With Geographic Atrophy

This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
      • Freiburg, Germany, 79106
      • Heidelberg, Germany, 69120
      • Leipzig, Germany, 04103
      • Munster, Germany, 48145
      • Tuebingen, Germany, 72076
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
    • California
      • Beverly Hills, California, United States, 90211
      • San Francisco, California, United States, 94107
      • Santa Barbara, California, United States, 93103
      • Torrance, California, United States, 90503
    • Florida
      • Boynton Beach, Florida, United States, 33426
      • Fort Lauderdale, Florida, United States, 33334
      • Palm Beach Gardens, Florida, United States, 33410
      • Pensacola, Florida, United States, 32503
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Kentucky
      • Paducah, Kentucky, United States, 42001
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Edina, Minnesota, United States, 55435
    • New York
      • Lynbrook, New York, United States, 11563
      • New York, New York, United States, 10003
      • Rochester, New York, United States, 14642
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
    • Ohio
      • Beachwood, Ohio, United States, 44122
      • Cincinnati, Ohio, United States, 45242
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Abilene, Texas, United States, 79606
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75231
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willingness and ability to provide signed Informed Consent; in addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
  • Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)

Exclusion Criteria:

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation in the study eye
  • Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
  • GA in either eye due to causes other than AMD
  • Diabetic retinopathy in either eye
  • Active or history of wet AMD in either eye
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
  • Active malignancy or history of malignancy within the past 5 years
  • Previous participation in any studies of investigational drugs within 3 months preceding Day 0

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FCFD4514S
Drug: FCFD4514S
Repeating intravitreal injection
Sham Comparator: sham
Drug: sham
Repeating sham injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth rate of geographic atrophy (GA) lesion area from baseline
Time Frame: Month 18
Month 18

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in best corrected visual acuity (BCVA) from baseline
Time Frame: Month 18
Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Erich Strauss, M.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 27, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFD4870g
  • GX01456 (Other Identifier: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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