Phase 2
N=191
Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Atrophy, Geographic
Bottom Line
View on ClinicalTrials.gov: NCT01342926 ↗Enrolled (actual)
191
Serious AEs
21.5%
Results posted
May 2017
Primary outcome: Primary: Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye — -0.52; -0.94; -0.99; -0.96 square millimeter (m^2)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK933776 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye |
-0.52; -0.94; -0.99; -0.96; 0.95; 0.88 | — |
| PRIMARY Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period |
41; 42; 44; 47; 12; 17 | — |
| PRIMARY Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period |
8; 11; 9; 12; 1; 0 | — |
| PRIMARY Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
1; 3; 2; 5; 1; 2 | — |
| PRIMARY Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) |
1; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) |
0; 0; 1; 1; 2; 4 | — |
| SECONDARY Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye |
-0.70; -0.62; -0.74; -0.74; 0.81; 0.94 | — |
| SECONDARY Change From Baseline in Area of Total hypoAF in Study Eye |
-0.65; -0.63; -0.71; -1.20; 0.91; 1.01 | — |
| SECONDARY 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 |
1; 0; 1; 1; 3; 0 | — |
| SECONDARY Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 |
0.2; 2.6; 0.6; 0.1; 0.7; 0.3 | — |
| SECONDARY 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 |
16725.96; 29717.17; 69485.24 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants |
82311.15; 142728.2; 350716.9; 8551.70; 15512.19; 37589.25 | — |
| SECONDARY Clearance (CL) of GSK933776 in Geographic Atrophy Participants |
14.66; 14.90; 16.09 | — |
| SECONDARY Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants |
11.67; 11.87; 11.27 | — |
| SECONDARY Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling |
5618.72; 5825.03; 5959.42 | — |
| SECONDARY 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) |
715.69; 702.63; 729.12; 709.04; 675.95; 833.22 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01342926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.