Trial record 3 of 4 for:    lampalizumab

A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (SPECTRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02247531
First received: July 15, 2014
Last updated: July 1, 2016
Last verified: July 2016
  Purpose
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).

Condition Intervention Phase
Geographic Atrophy
Drug: Lampalizumab
Other: Sham
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in GA area, as assessed by retinal imaging [ Time Frame: From baseline to Week 48 ]

Secondary Outcome Measures:
  • Change in best corrected visual acuity (BCVA) [ Time Frame: From baseline to 2 years ]
  • Change in additional measures of visual function [ Time Frame: From baseline to 2 years ]

Estimated Enrollment: 936
Study Start Date: October 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Q4W Lampalizumab Drug: Lampalizumab
10-mg dose of lampalizumab administered intravitrally
Other Name: RO5490249
Experimental: Q6W Lampalizumab Drug: Lampalizumab
10-mg dose of lampalizumab administered intravitrally
Other Name: RO5490249
Sham Comparator: Sham Other: Sham
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02247531

Contacts
Contact: Reference Study ID Number: GX29185 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Arizona
Active, not recruiting
Phoenix, Arizona, United States, 85020
Active, not recruiting
Tucson, Arizona, United States, 85750
United States, California
Recruiting
Fullerton, California, United States, 92835
Recruiting
La Jolla, California, United States, 92093-0946
Recruiting
Los Angeles, California, United States, 90095-7000
Active, not recruiting
Mountain View, California, United States, 94040
Recruiting
Palo Alto, California, United States, 94303
Recruiting
Poway, California, United States, 92064
Recruiting
Sacramento, California, United States, 95817
Recruiting
Sacramento, California, United States, 95841
Active, not recruiting
Santa Barbara, California, United States, 93103
Active, not recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
Recruiting
Colorado Springs, Colorado, United States, 80909
Recruiting
Golden, Colorado, United States, 80201
United States, Connecticut
Recruiting
Hamden, Connecticut, United States, 06518
Active, not recruiting
New London, Connecticut, United States, 06320
United States, Florida
Active, not recruiting
Fort Myers, Florida, United States, 33907
Recruiting
Ft Lauderdale, Florida, United States, 33308
Recruiting
Naples, Florida, United States, 34103
Active, not recruiting
St. Petersburg, Florida, United States, 33711
Active, not recruiting
Tallahassee, Florida, United States, 32308
Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30322
United States, Iowa
Active, not recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
Recruiting
Wichita, Kansas, United States, 67214
United States, Kentucky
Recruiting
Paducah, Kentucky, United States, 42001
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21209
Active, not recruiting
Baltimore, Maryland, United States, 21287
Recruiting
Chevy Chase, Maryland, United States, 20815
Active, not recruiting
Towson, Maryland, United States, 21204
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Active, not recruiting
Ann Arbor, Michigan, United States, 48105
Active, not recruiting
Detroit, Michigan, United States, 48201-1423
United States, Minnesota
Active, not recruiting
Edina, Minnesota, United States, 55435
United States, Missouri
Active, not recruiting
Chesterfield, Missouri, United States, 63017
United States, Nebraska
Recruiting
Omaha, Nebraska, United States, 68105
United States, Nevada
Recruiting
Reno, Nevada, United States, 89502
United States, New Jersey
Active, not recruiting
Northfield, New Jersey, United States, 08225
Recruiting
Teaneck, New Jersey, United States, 07666
United States, New York
Recruiting
New York, New York, United States, 10021
Recruiting
New York, New York, United States, 10022
Active, not recruiting
Rochester, New York, United States, 14620
United States, North Carolina
Recruiting
Asheville, North Carolina, United States, 28803
Recruiting
Charlotte, North Carolina, United States, 28210
Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Active, not recruiting
Cincinnati, Ohio, United States, 45242
Active, not recruiting
Columbus, Ohio, United States, 43212
United States, Oregon
Active, not recruiting
Ashland, Oregon, United States, 97520
Recruiting
Portland, Oregon, United States, 97210
Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Active, not recruiting
Pittburgh, Pennsylvania, United States, 15212
United States, South Carolina
Active, not recruiting
Charleston, South Carolina, United States
Active, not recruiting
Ladson, South Carolina, United States, 29456
Recruiting
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Active, not recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Recruiting
Chattnooga, Tennessee, United States
Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Recruiting
Abilene, Texas, United States, 79606
Active, not recruiting
Dallas, Texas, United States, 75231
Recruiting
Houston, Texas, United States, 77030
Active, not recruiting
Temple, Texas, United States, 76504
Recruiting
The Woodlands, Texas, United States, 77384
United States, Virginia
Recruiting
Charlottesville, Virginia, United States, 22903
United States, Washington
Recruiting
Bellevue, Washington, United States, 98114
Argentina
Recruiting
Capital Federal, Argentina, C1120AAN
Recruiting
Capital Federal, Argentina, C1122AAI
Recruiting
Florencio Varela, Argentina, B1888AAE
Australia, Queensland
Recruiting
Brisbane, Queensland, Australia, 4101
Australia, South Australia
Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Recruiting
Box Hill, Victoria, Australia, 3128
Recruiting
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Austria
Recruiting
Wien, Austria, 1090
Belgium
Active, not recruiting
Bruxelles, Belgium, 1020
Recruiting
Leuven, Belgium, 3000
Denmark
Active, not recruiting
Glostrup, Denmark, 2600
France
Recruiting
Bordeaux, France, 33000
Recruiting
Dijon, France, 21079
Recruiting
Lyon cedex, France, 69317
Recruiting
Marseille, France, 13008
Recruiting
Nantes, France, 44093
Recruiting
Paris, France, 75012
Germany
Recruiting
Freiburg, Germany, 79106
Recruiting
Heidelberg, Germany, 69120
Recruiting
Ludwigshafen, Germany, 67063
Recruiting
Mainz, Germany, 55131
Recruiting
München, Germany, 80336
Recruiting
München, Germany, 81675
Recruiting
Regensburg, Germany, 93053
Recruiting
Tuebingen, Germany, 72076
Hungary
Recruiting
Budapest, Hungary, 1083
Recruiting
Budapest, Hungary
Recruiting
Pecs, Hungary, 7621
Italy
Recruiting
Genova, Liguria, Italy, 16132
Active, not recruiting
Milano, Lombardia, Italy, 20132
Active, not recruiting
Milano, Lombardia, Italy, 20157
Recruiting
Torino, Piemonte, Italy, 10122
Recruiting
Firenze, Toscana, Italy, 50134
Active, not recruiting
Udine, Veneto, Italy, 33100
Mexico
Recruiting
Mexico City, Mexico, 06030
Recruiting
Monterrey, Mexico, 64040
Active, not recruiting
Querétaro, Mexico, 76090
Netherlands
Active, not recruiting
Nijmegen, Netherlands, 6525 EX
Recruiting
Rotterdam, Netherlands, 3015 CE
Peru
Recruiting
Lima, Peru, 27
Recruiting
Lima, Peru, 33
Poland
Recruiting
Bydgoszcz, Poland, 85-631
Recruiting
Bytom, Poland, 41-902
Recruiting
Wrocław, Poland, 50-556
Recruiting
Łódź, Poland, 91-134
Portugal
Recruiting
Coimbra, Portugal, 3000-548
Recruiting
Coimbra, Portugal, 3030-163
Recruiting
Lisboa, Portugal, 1649-035
Recruiting
Porto, Portugal, 4200-319
Russian Federation
Recruiting
Kazan, Russian Federation, 420012
Recruiting
Moscow, Russian Federation, 119435
Recruiting
Samara, Russian Federation, 443068
Slovakia
Recruiting
Banska Bystrica, Slovakia, 975 17
Recruiting
Bratislava, Slovakia, 851 07
Spain
Active, not recruiting
Santiago de Compostela, La Coruña, Spain, 15706
Recruiting
Pamplona, Navarra, Spain, 31008
Active, not recruiting
Albacete, Spain, 02006
Recruiting
Barcelona, Spain, 08035
Active, not recruiting
Madrid, Spain, 28002
Active, not recruiting
Madrid, Spain, 28040
Active, not recruiting
Valencia, Spain, 46026
Sweden
Recruiting
Stockholm, Sweden, SE-112 82
Switzerland
Active, not recruiting
Bern, Switzerland, 3010
Active, not recruiting
Binningen, Switzerland, 4102
Turkey
Active, not recruiting
Ankara, Turkey, 06100
Recruiting
Ankara, Turkey, 06340
Recruiting
Ankara, Turkey, 06490
Recruiting
Istanbul, Turkey, 34093
Recruiting
Izmir, Turkey, 35100
Active, not recruiting
Izmir, Turkey, 35340
United Kingdom
Recruiting
Belfast, United Kingdom, BT12 6BA
Active, not recruiting
Bradford, United Kingdom, BD9 6RJ
Active, not recruiting
Bristol, United Kingdom, BS1 2LX
Active, not recruiting
Cardiff, United Kingdom, CF14 4XW
Recruiting
Gloucestershire, United Kingdom, GL1 3NN
Recruiting
Liverpool, United Kingdom, L7 8XP
Recruiting
London, United Kingdom, EC1V 2PD
Active, not recruiting
London, United Kingdom, SE5 9RF
Active, not recruiting
Manchester, United Kingdom, M13 9WL
Recruiting
Middx, United Kingdom, UB8 3NN
Active, not recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
Recruiting
Southampton, United Kingdom, SO16 6YD
Active, not recruiting
Wolverhampton, United Kingdom, WV10 0QP
Active, not recruiting
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02247531     History of Changes
Other Study ID Numbers: GX29185  2014-000106-35 
Study First Received: July 15, 2014
Last Updated: July 1, 2016

Additional relevant MeSH terms:
Atrophy
Macular Degeneration
Geographic Atrophy
Pathological Conditions, Anatomical
Retinal Degeneration
Retinal Diseases
Eye Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 19, 2017