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History of Changes for Study: NCT02247479
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (CHROMA)
Latest version (submitted June 17, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 19, 2014 None (earliest Version on record)
2 November 3, 2014 Contacts/Locations, Study Status, Arms and Interventions and Study Description
3 November 10, 2014 Contacts/Locations and Study Status
4 November 17, 2014 Contacts/Locations and Study Status
5 December 8, 2014 Contacts/Locations and Study Status
6 December 23, 2014 Contacts/Locations and Study Status
7 December 29, 2014 Contacts/Locations and Study Status
8 January 6, 2015 Study Status and Contacts/Locations
9 January 19, 2015 Contacts/Locations and Study Status
10 January 26, 2015 Contacts/Locations and Study Status
11 February 5, 2015 Contacts/Locations, Study Status and Study Description
12 February 19, 2015 Contacts/Locations and Study Status
13 February 23, 2015 Contacts/Locations and Study Status
14 March 2, 2015 Study Status
15 March 9, 2015 Contacts/Locations and Study Status
16 March 16, 2015 Contacts/Locations and Study Status
17 March 23, 2015 Contacts/Locations and Study Status
18 April 2, 2015 Contacts/Locations and Study Status
19 May 5, 2015 Study Status
20 May 11, 2015 Contacts/Locations and Study Status
21 May 29, 2015 Contacts/Locations and Study Status
22 June 1, 2015 Study Status and Contacts/Locations
23 July 1, 2015 Contacts/Locations and Study Status
24 July 31, 2015 Study Status and Contacts/Locations
25 August 17, 2015 Study Status and Contacts/Locations
26 September 1, 2015 Study Status and Contacts/Locations
27 September 9, 2015 Contacts/Locations and Study Status
28 October 1, 2015 Contacts/Locations and Study Status
29 November 2, 2015 Contacts/Locations and Study Status
30 December 1, 2015 Contacts/Locations and Study Status
31 December 31, 2015 Contacts/Locations and Study Status
32 February 1, 2016 Contacts/Locations and Study Status
33 February 11, 2016 Contacts/Locations, Outcome Measures, Study Status, Study Identification and Study Description
34 March 1, 2016 Contacts/Locations and Study Status
35 April 2, 2016 Contacts/Locations and Study Status
36 May 4, 2016 Contacts/Locations and Study Status
37 June 1, 2016 Contacts/Locations and Study Status
38 July 1, 2016 Contacts/Locations and Study Status
39 August 1, 2016 Study Status and Contacts/Locations
40 September 1, 2016 Study Status and Contacts/Locations
41 October 3, 2016 Contacts/Locations and Study Status
42 November 1, 2016 Study Status and Contacts/Locations
43 June 29, 2017 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Arms and Interventions, Study Identification, Study Design, Oversight and Eligibility
44 September 11, 2017 Study Status and Contacts/Locations
45 November 7, 2017 Study Status, Contacts/Locations and Study Design
46 November 8, 2017 Study Status
47 November 29, 2017 Study Status
48 December 12, 2017 Study Status
49 January 15, 2018 Study Status and Contacts/Locations
50 March 12, 2018 Study Status and Contacts/Locations
51 March 16, 2018 Recruitment Status and Study Status
52 April 17, 2018 Recruitment Status and Study Status
53 May 2, 2018 Contacts/Locations and Study Status
54 May 30, 2018 Study Status
55 June 25, 2018 Contacts/Locations and Study Status
56 August 14, 2018 Study Status
57 September 13, 2018 Recruitment Status, Contacts/Locations and Study Status
58 October 18, 2018 Recruitment Status, Study Status
Show
Results Submission Events
59 April 19, 2019 Recruitment Status, Outcome Measures, Study Status, More Information, Contacts/Locations, Arms and Interventions, Document Section, Adverse Events, Baseline Characteristics, Participant Flow and Eligibility
60 June 17, 2019 Study Status and Contacts/Locations
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Study NCT02247479
Submitted Date:  September 19, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: GX29176
Brief Title: A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (CHROMA)
Official Title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION
Secondary IDs: 2014-000107-27 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2014
Overall Status: Recruiting
Study Start: September 2014
Primary Completion: October 2018 [Anticipated]
Study Completion: October 2018 [Anticipated]
First Submitted: July 15, 2014
First Submitted that
Met QC Criteria:
September 19, 2014
First Posted: September 25, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 19, 2014
Last Update Posted: September 25, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Detailed Description:
Open or close this module Conditions
Conditions: Geographic Atrophy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 936 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Q4W Lampalizumab Drug: Lampalizumab
10-mg dose of lampalizumab administered intravitrally
Experimental: Q6W Lampalizumab Drug: Lampalizumab
10-mg dose of lampalizumab administered intravitrally
Sham Comparator: Sham
Sham
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in GA area, as assessed by retinal imaging
[ Time Frame: From baseline to Week 48 ]

Secondary Outcome Measures:
1. Change in best corrected visual acuity (BCVA)
[ Time Frame: From baseline to 2 years ]

2. Change in additional measures of visual function
[ Time Frame: from baseline to 2 years ]

Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Participants aged >/= 50 years
  • Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion Criteria:

Ocular Exclusion Criteria: Study Eye

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
  • Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria: Both Eyes
  • GA in either eye due to causes other than AMD
  • Previous treatment with eculizumab, lampalizumab and/or fenretinide
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: GX29176 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. Only)
Email: global.rochegenentechtrials@roche.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, Alabama
[Not yet recruiting]
Birmingham, Alabama, United States, 35233
United States, Arizona
[Not yet recruiting]
Phoenix, Arizona, United States, 85012
[Recruiting]
Tucson, Arizona, United States, 85704
United States, California
[Not yet recruiting]
Beverly Hills, California, United States
[Not yet recruiting]
Irvine, California, United States, 92697-4375
[Not yet recruiting]
Los Angeles, California, United States, 90095-7000
[Not yet recruiting]
Oakland, California, United States, 94609
[Not yet recruiting]
Palm Desert, California, United States, 92211
[Not yet recruiting]
San Francisco, California, United States, 94107
[Not yet recruiting]
Santa Ana, California, United States, 92705
United States, Florida
[Recruiting]
Boynton Beach, Florida, United States, 33426
[Not yet recruiting]
Fort Myers, Florida, United States, 33912
[Not yet recruiting]
Melbourne, Florida, United States, 329001
[Recruiting]
Palm Beach Gardens, Florida, United States, 33410
[Not yet recruiting]
Palm Beach Gardens, Florida, United States, 33418
[Recruiting]
Pensacola, Florida, United States, 32503
[Not yet recruiting]
Pensacola, Florida, United States, 32503
[Not yet recruiting]
Plantation, Florida, United States, 33324
[Not yet recruiting]
Tampa, Florida, United States, 33609
United States, Georgia
[Not yet recruiting]
Augusta, Georgia, United States, 30909
[Not yet recruiting]
Marietta, Georgia, United States, 30060
United States, Hawaii
[Not yet recruiting]
Aiea, Hawaii, United States, 96701
United States, Indiana
[Not yet recruiting]
Indianapolis, Indiana, United States, 46290
United States, Kansas
[Not yet recruiting]
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
[Not yet recruiting]
Lexington, Kentucky, United States, 40509
United States, Maine
[Not yet recruiting]
Portland, Maine, United States, 04102
United States, Maryland
[Not yet recruiting]
Lutherville, Maryland, United States, 21093
United States, Massachusetts
[Not yet recruiting]
Boston, Massachusetts, United States, 02111
[Recruiting]
Boston, Massachusetts, United States, 02114
[Not yet recruiting]
Burlington, Massachusetts, United States, 01805
[Not yet recruiting]
Worcester, Massachusetts, United States, 01605
United States, Michigan
[Not yet recruiting]
Grand Rapids, Michigan, United States, 49546
[Not yet recruiting]
Jackson, Michigan, United States, 49202
[Not yet recruiting]
Royal Oak, Michigan, United States, 48073
[Not yet recruiting]
Southfield, Michigan, United States, 48034
United States, Nebraska
[Not yet recruiting]
Lincoln, Nebraska, United States, 68506
United States, Nevada
[Not yet recruiting]
Henderson, Nevada, United States, 89052
United States, New Jersey
[Not yet recruiting]
Bloomfield, New Jersey, United States, 7003
[Not yet recruiting]
Lawrenceville, New Jersey, United States, 08648
[Not yet recruiting]
New Brunswick, New Jersey, United States, 08901
United States, New York
[Not yet recruiting]
Great Neck, New York, United States, 11021
[Not yet recruiting]
Lynbrook, New York, United States, 11563
[Not yet recruiting]
Orchard Park, New York, United States, 14127
[Not yet recruiting]
Syracuse, New York, United States, 13224
United States, North Carolina
[Not yet recruiting]
Greensboro, North Carolina, United States, 27401
United States, Ohio
[Not yet recruiting]
Beachwood, Ohio, United States, 44122
United States, Pennsylvania
[Not yet recruiting]
Johnstown, Pennsylvania, United States, 15904
[Not yet recruiting]
West Mifflin, Pennsylvania, United States, 15122
United States, Tennessee
[Recruiting]
Nashville, Tennessee, United States, 37203
[Not yet recruiting]
Nashville, Tennessee, United States, 37232
United States, Texas
[Not yet recruiting]
Arlington, Texas, United States, 76012
[Recruiting]
Austin, Texas, United States, 78705
[Not yet recruiting]
Austin, Texas, United States, 78705
[Not yet recruiting]
Dallas, Texas, United States, 75390
[Not yet recruiting]
McAllen, Texas, United States, 78503
[Not yet recruiting]
Willow Park, Texas, United States, 76087
United States, Utah
[Not yet recruiting]
Salt Lake City, Utah, United States, 84103
United States, Virginia
[Not yet recruiting]
Richmond, Virginia, United States, 23226
[Not yet recruiting]
Richmond, Virginia, United States, 23235
[Not yet recruiting]
Warrenton, Virginia, United States, 20132
United States, Washington
[Not yet recruiting]
Silverdale, Washington, United States, 98383
[Not yet recruiting]
Spokane, Washington, United States, 99204
United States, West Virginia
[Not yet recruiting]
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
[Not yet recruiting]
Madison, Wisconsin, United States, 53705
Argentina
[Not yet recruiting]
Buenos Aires, Argentina, C1015ABO
[Not yet recruiting]
Caba, Argentina, 1023
[Not yet recruiting]
Rosario, Argentina
Australia, New South Wales
[Not yet recruiting]
Albury, New South Wales, Australia, 2640
[Not yet recruiting]
Parramatta, New South Wales, Australia, 2150
[Not yet recruiting]
Sydney, New South Wales, Australia, 2000
Canada, Alberta
[Not yet recruiting]
Calgary, Alberta, Canada, T2J 0C8
Canada, British Columbia
[Not yet recruiting]
Vancouver, British Columbia, Canada, V5Z 3N9
Canada, Ontario
[Not yet recruiting]
Toronto, Ontario, Canada, M4N 3M5
[Not yet recruiting]
Toronto, Ontario, Canada, M5G 2C4
[Not yet recruiting]
Toronto, Ontario, Canada, M5T 2S8
Denmark
[Not yet recruiting]
Aarhus C, Denmark, 8000
[Not yet recruiting]
Roskilde, Denmark, 4000
Germany
[Not yet recruiting]
Bonn, Germany, 53127
[Not yet recruiting]
Göttingen, Germany, 37075
[Not yet recruiting]
Köln, Germany, 50935
[Not yet recruiting]
Köln, Germany, 50937
[Not yet recruiting]
Lübeck, Germany, 23538
[Not yet recruiting]
Münster, Germany, 48145
[Not yet recruiting]
Münster, Germany, 48149
Hungary
[Not yet recruiting]
Budapest, Hungary, 1133
Italy, Friuli-Venezia Giulia
[Not yet recruiting]
Trieste, Friuli-Venezia Giulia, Italy, 34129
Italy, Lazio
[Not yet recruiting]
Roma, Lazio, Italy, 00138
[Not yet recruiting]
Roma, Lazio, Italy, 00184
Italy, Lombardia
[Not yet recruiting]
Milano, Lombardia, Italy, 20100
Italy, Sardegna
[Not yet recruiting]
Sassari, Sardegna, Italy, 07100
Italy, Veneto
[Not yet recruiting]
Padova, Veneto, Italy, 35128
Peru
[Not yet recruiting]
Lima, Peru, Lima 27
Poland
[Not yet recruiting]
Gdansk, Poland, 80-809
[Not yet recruiting]
Katowice, Poland, 40-594
[Not yet recruiting]
Krakow, Poland, 31-501
Portugal
[Not yet recruiting]
Lisboa, Portugal, 1649-035
[Not yet recruiting]
Porto, Portugal, 4200-319
Switzerland
[Not yet recruiting]
Zürich, Switzerland, 8063
United Kingdom
[Not yet recruiting]
AYR, United Kingdom, KA6 6DX
[Not yet recruiting]
Belfast, United Kingdom, BT12 6BA
[Not yet recruiting]
Bradford, United Kingdom, BD9 6RJ
[Not yet recruiting]
Inverness, United Kingdom, IV2 3UV
[Not yet recruiting]
Manchester, United Kingdom, M13 9WL
[Not yet recruiting]
Newcastle upon Tyne, United Kingdom, NE1 4LP
[Not yet recruiting]
Rugby, United Kingdom, CV22 5PX
[Not yet recruiting]
Sheffield, United Kingdom, S10 2JF
[Not yet recruiting]
York, United Kingdom, YO31 8HE
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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