Clinical study to investigate safety and efficacy of GSK933776 in adult patients with geographic atrophy secondary to age-related macular degeneration
Trial overview
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
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
Participation criteria
- 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
- 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
- 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)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.