Clinical trial NCT01229215: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Geographic Atrophy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 143
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Growth rate of geographic atrophy (GA) lesion area from baseline
timeFrame: Month 18
Secondary outcomes:
measure: Mean change in best corrected visual acuity (BCVA) from baseline
timeFrame: Month 18
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Torrance
country: United States
state: California
city: Boynton Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Paducah
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Edina
country: United States
state: Minnesota
city: Lynbrook
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: West Columbia
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
city: Bonn
country: Germany
city: Freiburg
country: Germany
city: Heidelberg
country: Germany
city: Leipzig
country: Germany
city: Munster
country: Germany
city: Tuebingen
country: Germany
Study officials:
affiliation: Genentech, Inc.
name: Erich Strauss, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.