Last updated: 07/17/2024 15:38:56

Clinical study to investigate safety and efficacy of GSK933776 in adult patients with geographic atrophy secondary to age-related macular degeneration

GSK study ID
114341
See study documents
Clinicaltrials.gov ID
NCT01342926
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A phase 2, multi-centre, randomised, double-masked, placebo-controlled, parallel-group study to investigate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GSK933776 in adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
Trial description: The purpose of this study is to determine the safety and efficacy of GSK933776 in the treatment of geographic atrophy secondary to age-related macular degeneration.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in the area of geographic atrophy (GA) assessed by color fundus photographs (FP) in the study eye

Timeframe: Baseline (BL), 6 months, 12 months and 18 months

Number of participants with ocular or non-ocular adverse events (AEs) during the treatment period

Timeframe: Up to 21 months

Number of participants with ocular or non-ocular serious adverse events (SAEs) during the treatment period

Timeframe: Up to 21 months

Number of participants with vital signs of Potential Clinical Importance (PCI) during the treatment period: systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Timeframe: Up to 21 months

Number of participants with vital signs of Potential Clinical Importance (PCI) during the treatment period: heart rate (HR)

Timeframe: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit

Number of participants with 12-lead electrocardiogram (ECG) of Potential Clinical Importance (PCI)

Timeframe: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit

Number of participants with abnormal laboratory parameter values of Potential Clinical Importance (PCI)

Timeframe: At any point from Baseline through follow-up visit.

Number of participants with abnormal magnetic resonance imaging (MRI)

Timeframe: Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal

Secondary outcomes:

Change from Baseline in area of GA assessed by fundus autofluorescence images (hypoAF) corresponding to GA in study eye

Timeframe: Baseline, 6 months, 12 months and 18 months

Change from Baseline in area of total hypoAF in study eye

Timeframe: Baseline, 6 months, 12 months and 18 months

Number of participants losing letters in early treatment diabetic retinopathy study (ETDRS)-best corrected visual acuity (BCVA) Score at Month 12 and Month 18 for each eye

Timeframe: Month 12 and Month 18

Mean change in ETDRS-BCVA score from Baseline at every month up to Month 18

Timeframe: Baseline and every month up to Month 18

Area under the plasma concentration-time curve from time 0 to the end of dosing interval at steady-state (AUC0-28d) of GSK933776 in geographic atrophy participants

Timeframe: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476

Maximum observed plasma concentration (Cmax) and pre-dose (trough) concentration at the end of the dosing interval (Ctau) of GSK933776 in geographic atrophy participants

Timeframe: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476

Clearance (CL) of GSK933776 in geographic atrophy participants

Timeframe: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476

Estimation of terminal phase half-life (T1/2) of GSK933776 in geographic atrophy participants

Timeframe: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476

Volume of distribution at steady-state (Vdss) of GSK933776 in geographic atrophy participants estimated from population PK modeling

Timeframe: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476

The pharmacodynamic effects of GSK933776 total (bound and unbound) plasma total amyloid beta (Abeta42), and amyloid beta fragments (Abeta18-35), if possible, unbound plasma Aβ fragments (Abeta1-22)

Timeframe: Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18

Interventions:
  • Drug: GSK933776
  • Drug: Placebo
    • Enrollment:
    191
    Primary completion date:
    2016-05-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Philip J. Rosenfeld, Brian Berger, Elias Reichel, Ronald P. Danis, Angie Gress, Li Ye, Mindy Magee, Laura R. Parham, Megan McLaughlin. A Phase 2 Study with an Anti-Amyloid ß Monoclonal Antibody in Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmol Retina. 2018
    Medical condition
    Atrophy, Geographic
    Product
    GSK933776
    Collaborators
    Not applicable
    Study date(s)
    June 2011 to April 2016
    Type
    Interventional
    Phase
    1/2

    Participation criteria

    Sex
    Female & Male
    Age
    55+ years
    Accepts healthy volunteers
    No
    • Adult patients ≥55 years of age inclusive
    • Evidence of AMD confirmed by the presence of at least 1 druse ≥125 μm diameter
    • Additional eye disease in the study eye that could compromise assessment of best-corrected visual acuity or imaging of the posterior pole
    • History of CNV secondary to AMD in the study eye
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Adult patients ≥55 years of age inclusive
    • Evidence of AMD confirmed by the presence of at least 1 druse ≥125 μm diameter
    • Well-demarcated GA due to AMD of total area 1.9-17 mm2 measured in the study eye
    • Best-corrected visual acuity score of ≥ 35 letters (approximately 20/200 Snellen VA equivalent or better) in the study eye
    Exclusion criteria:
    • Additional eye disease in the study eye that could compromise assessment of best-corrected visual acuity or imaging of the posterior pole
    • History of CNV secondary to AMD in the study eye
    • Any previous treatment for AMD in the study eye, approved or investigational, with the exception of dietary supplements
    • Risk of cerebrovascular disease, cerebral hemorrhage or stroke
    • History of systemic autoimmune disease
    • Use of platelet anti-aggregants or anti-coagulants (aspirin up to 325 mg/day is allowable, or in subjects allergic or intolerable to aspirin, clopidogrel up to 75 mg/day is allowable)
    • Use of chronic corticosteroids
    • Uncontrolled hypertension in spite of antihypertensive medications
    • Renal or hepatic insufficiency or clinically significant anemia
    • More than moderate MRI white matter changes

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Galveston, Texas, United States, 77550
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Abilene, Texas, United States, 79606
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33612
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    La Jolla, California, United States, 92037
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Golden, Colorado, United States, 80401
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84132
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Arcadia, California, United States, 91007
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78705
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48202
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Silverdale, Washington, United States, 98383
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Torrance, California, United States, 90503
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Northfield, New Jersey, United States, 08225
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mississauga, Ontario, Canada, L4W 1W9
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    North Dartmouth, Massachusetts, United States, 02747
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    West Mifflin, Pennsylvania, United States, 15122
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21204
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    New Albany, Indiana, United States, 47150
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    New York, New York, United States, 10003
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33136
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Palm Desert, California, United States, 92260
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Toms River, New Jersey, United States, 08755
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85020
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Augusta, Georgia, United States, 30909
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46290
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Stuart, Florida, United States, 34994
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19107
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Prairie Village, Kansas, United States, 66208
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21287
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90033-4500
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Paducah, Kentucky, United States, 42001
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ladson, South Carolina, United States, 29406
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Irvine, California, United States, 92697
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Leawood, Kansas, United States, 66211
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40215
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85014
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Charlottesville, Virginia, United States, 22903
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02111
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Francisco, California, United States, 94143
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Altamonte Springs, Florida, United States, 32701
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Arlington, Texas, United States, 76012
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Asheville, North Carolina, United States, 28803
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30322
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21237
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Baton Rouge, Louisiana, United States, 70807
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Beverly Hills, California, United States, 90211
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02114
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60612
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60637
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60657
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Cincinatti, Ohio, United States, 45242
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44195
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75231
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30030
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Ft. Lauderdale, Florida, United States, 33334
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Ft. Myers, Florida, United States, 33912
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Great Neck, New York, United States, 11021
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Greensboro, North Carolina, United States, 27401
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Honolulu, Hawaii, United States, 96815
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Honolulu, Hawaii, United States, 96819
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Iowa City, Iowa, United States, 52242-
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Kingston, Pennsylvania, United States, 18704
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40509-
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90033-
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53705
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Mississauga, Ontario, Canada, L4W 1W
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Missoula, Montana, United States, 59801
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Morgantown, West Virginia, United States, 26505
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37232
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    New London, Connecticut, United States, 006320
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    New York, New York, United States, 10022
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68198-
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Palm Beach Gardens, Florida, United States, 33410
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Palo Alto, California, United States, 94303
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15213
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97210
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97239
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Portsmouth, New Hampshire, United States, 03801
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Poway, California, United States, 92064
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Rapid City, South Dakota, United States, 57701
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23226
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Rochester, New York, United States, 14642
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Sacramento, California, United States, 95817
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Sacramento, California, United States, 95819
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84107
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    San Francisco, California, United States, 94115
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Santa Brbara, California, United States, 93103
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Sarasota, Florida, United States, 34239
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98104
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33609
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Teaneck, New Jersey, United States, 07666
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94598
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    West Columbia, South Carolina, United States, 29169
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27157
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Winter Haven, Florida, United States, 33880
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2016-05-04
    Actual study completion date
    2016-05-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website