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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01229215
Collaborator
(none)
143
Enrollment
36
Locations
2
Arms
26
Duration (Months)
4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 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

  1. Growth rate of geographic atrophy (GA) lesion area from baseline [Month 18]

Secondary Outcome Measures

  1. Mean change in best corrected visual acuity (BCVA) from baseline [Month 18]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Tucson Arizona United States 85704
2 Beverly Hills California United States 90211
3 San Francisco California United States 94107
4 Santa Barbara California United States 93103
5 Torrance California United States 90503
6 Boynton Beach Florida United States 33426
7 Fort Lauderdale Florida United States 33334
8 Palm Beach Gardens Florida United States 33410
9 Pensacola Florida United States 32503
10 Winter Haven Florida United States 33880
11 Augusta Georgia United States 30909
12 Paducah Kentucky United States 42001
13 Baltimore Maryland United States 21287
14 Boston Massachusetts United States 02114
15 Edina Minnesota United States 55435
16 Lynbrook New York United States 11563
17 New York New York United States 10003
18 Rochester New York United States 14642
19 Charlotte North Carolina United States 28210
20 Beachwood Ohio United States 44122
21 Cincinnati Ohio United States 45242
22 Portland Oregon United States 97210
23 Philadelphia Pennsylvania United States 19104
24 Philadelphia Pennsylvania United States 19107
25 West Columbia South Carolina United States 29169
26 Nashville Tennessee United States 37203
27 Abilene Texas United States 79606
28 Austin Texas United States 78705
29 Dallas Texas United States 75231
30 Milwaukee Wisconsin United States 53226
31 Bonn Germany 53127
32 Freiburg Germany 79106
33 Heidelberg Germany 69120
34 Leipzig Germany 04103
35 Munster Germany 48145
36 Tuebingen Germany 72076

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01229215
Other Study ID Numbers:
  • CFD4870g
  • GX01456
First Posted:
Oct 27, 2010
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Geographic Atrophy
Atrophy

Study Results

No Results Posted as of Nov 2, 2016