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

• ClinicalTrials.gov Identifier: NCT01229215
• Recruitment Status: Completed
• First Posted: October 27, 2010
• Last Update Posted: November 2, 2016
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: October 25, 2010
• First Posted Date: October 27, 2010
• Last Update Posted Date: November 2, 2016
• Study Start Date: February 2011
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 2, 2012): Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 18 ]
• Original Primary Outcome Measures (submitted: October 25, 2010): Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 12 ]
• Current Secondary Outcome Measures (submitted: October 25, 2010): Mean change in best corrected visual acuity (BCVA) from baseline [ Time Frame: Month 18 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Geographic Atrophy

Intervention

• Drug: FCFD4514S
  Repeating intravitreal injection
• Drug: sham
  Repeating sham injection

Study Arms

• Experimental: FCFD4514S
  Intervention: Drug: FCFD4514S
• Sham Comparator: sham
  Intervention: Drug: sham

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 21, 2012): 143
• Original Estimated Enrollment (submitted: October 25, 2010): 120
• Actual Study Completion Date: April 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, United States

Administrative Information

• NCT Number: NCT01229215
• Other Study ID Numbers: CFD4870g; GX01456 ( Other Identifier: Hoffmann-La Roche )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Disclosures Group, Genentech, Inc.
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Genentech, Inc.
• Verification Date: November 2016