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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2016-05-04
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
GSK Investigational Site
Galveston, Texas, United States, 77550
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92037
Status
Study Complete
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
Status
Study Complete
Location
GSK Investigational Site
Arcadia, California, United States, 91007
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Silverdale, Washington, United States, 98383
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90503
Status
Study Complete
Location
GSK Investigational Site
Northfield, New Jersey, United States, 08225
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Study Complete
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Mifflin, Pennsylvania, United States, 15122
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
New Albany, Indiana, United States, 47150
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10003
Status
Study Complete
Location
GSK Investigational Site
Palm Desert, California, United States, 92260
Status
Study Complete
Location
GSK Investigational Site
Toms River, New Jersey, United States, 08755
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85020
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30909
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46290
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Prairie Village, Kansas, United States, 66208
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21287
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033-4500
Status
Study Complete
Location
GSK Investigational Site
Paducah, Kentucky, United States, 42001
Status
Study Complete
Location
GSK Investigational Site
Ladson, South Carolina, United States, 29406
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92697
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40215
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22903
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02111
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94143
Status
Study Complete
Location
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Arlington, Texas, United States, 76012
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28803
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30322
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21237
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70807
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Beverly Hills, California, United States, 90211
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60657
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cincinatti, Ohio, United States, 45242
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dallas, Texas, United States, 75231
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Decatur, Georgia, United States, 30030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ft. Lauderdale, Florida, United States, 33334
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ft. Myers, Florida, United States, 33912
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Great Neck, New York, United States, 11021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96815
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96819
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Iowa City, Iowa, United States, 52242-
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kingston, Pennsylvania, United States, 18704
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40509-
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90033-
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53705
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Missoula, Montana, United States, 59801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37232
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New London, Connecticut, United States, 006320
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10022
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Omaha, Nebraska, United States, 68198-
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Palm Beach Gardens, Florida, United States, 33410
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Palo Alto, California, United States, 94303
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portsmouth, New Hampshire, United States, 03801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Poway, California, United States, 92064
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rapid City, South Dakota, United States, 57701
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Richmond, Virginia, United States, 23226
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, New York, United States, 14642
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sacramento, California, United States, 95817
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sacramento, California, United States, 95819
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santa Brbara, California, United States, 93103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sarasota, Florida, United States, 34239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seattle, Washington, United States, 98104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tampa, Florida, United States, 33609
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Teaneck, New Jersey, United States, 07666
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Columbia, South Carolina, United States, 29169
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winter Haven, Florida, United States, 33880
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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
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Access to clinical trial data by researchers
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