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

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ClinicalTrials.gov Identifier: NCT01229215

Recruitment Status : Completed

First Posted : October 27, 2010

Last Update Posted : November 2, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Genentech, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Geographic Atrophy	Drug: FCFD4514S Drug: sham	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	143 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	February 2011
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: FCFD4514S	Drug: FCFD4514S Repeating intravitreal injection
Sham Comparator: sham	Drug: sham Repeating sham injection

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	60 Years to 89 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229215

Locations

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United States, Arizona

Tucson, Arizona, United States, 85704
United States, California

Beverly Hills, California, United States, 90211

San Francisco, California, United States, 94107

Santa Barbara, California, United States, 93103

Torrance, California, United States, 90503
United States, 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
United States, Georgia

Augusta, Georgia, United States, 30909
United States, Kentucky

Paducah, Kentucky, United States, 42001
United States, Maryland

Baltimore, Maryland, United States, 21287
United States, Massachusetts

Boston, Massachusetts, United States, 02114
United States, Minnesota

Edina, Minnesota, United States, 55435
United States, New York

Lynbrook, New York, United States, 11563

New York, New York, United States, 10003

Rochester, New York, United States, 14642
United States, North Carolina

Charlotte, North Carolina, United States, 28210
United States, Ohio

Beachwood, Ohio, United States, 44122

Cincinnati, Ohio, United States, 45242
United States, Oregon

Portland, Oregon, United States, 97210
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina

West Columbia, South Carolina, United States, 29169
United States, Tennessee

Nashville, Tennessee, United States, 37203
United States, Texas

Abilene, Texas, United States, 79606

Austin, Texas, United States, 78705

Dallas, Texas, United States, 75231
United States, Wisconsin

Milwaukee, Wisconsin, United States, 53226
Germany

Bonn, Germany, 53127

Freiburg, Germany, 79106

Heidelberg, Germany, 69120

Leipzig, Germany, 04103

Munster, Germany, 48145

Tuebingen, Germany, 72076

Sponsors and Collaborators

Genentech, Inc.

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sivaprasad S, Tschosik E, Kapre A, Varma R, Bressler NM, Kimel M, Dolan C, Silverman D. Reliability and Construct Validity of the NEI VFQ-25 in a Subset of Patients With Geographic Atrophy From the Phase 2 Mahalo Study. Am J Ophthalmol. 2018 Jun;190:1-8. doi: 10.1016/j.ajo.2018.03.006. Epub 2018 Mar 10.

Kimel M, Leidy NK, Tschosik E, Dolan C, Souied EH, Varma R, Bressler NM. Functional Reading Independence (FRI) Index: A New Patient-Reported Outcome Measure for Patients With Geographic Atrophy. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6298-6304. doi: 10.1167/iovs.16-20361. Erratum In: Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3825.

Hariri A, Nittala MG, Sadda SR. Outer retinal tubulation as a predictor of the enlargement amount of geographic atrophy in age-related macular degeneration. Ophthalmology. 2015 Feb;122(2):407-13. doi: 10.1016/j.ophtha.2014.08.035. Epub 2014 Oct 12.

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Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT01229215
Other Study ID Numbers:	CFD4870g GX01456 ( Other Identifier: Hoffmann-La Roche )
First Posted:	October 27, 2010 Key Record Dates
Last Update Posted:	November 2, 2016
Last Verified:	November 2016

Additional relevant MeSH terms:

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Geographic Atrophy Atrophy Pathological Conditions, Anatomical Macular Degeneration	Retinal Degeneration Retinal Diseases Eye Diseases

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