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NCT01342926

Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

Completed Phase 2 Results posted Last updated 5 May 2017
What this trial tests

Phase 2 trial testing GSK933776 in Atrophy, Geographic in 191 participants. Completed in 1 April 2016.

Timeline
1 June 2011
Primary endpoint
1 April 2016
1 April 2016

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment191
Start date1 June 2011
Primary completion1 April 2016
Estimated completion1 April 2016
Sites41 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

55 and older, any sex, with Atrophy, Geographic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye Primary · Baseline (BL), 6 months, 12 months and 18 months

Atrophic age-related macular degeneration (AMD) also called GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by color FP at the indicated time points: screening, 6 months, 12 months and 18 months. Change from BL: (screening, month 6, 12 or 18 value minus BL value. Note screening occurs prior to BL). Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Efficacy Population: all participants in the Intent-to-T

Screening, n=34, 30, 35, 40
GroupValue95% CI
Placebo-0.52-0.86 – -0.17
GSK933776 (3 mg/kg)-0.94-1.30 – -0.57
GSK933776 (6 mg/kg)-0.99-1.33 – -0.65
GSK933776 (15 mg/kg)-0.96-1.28 – -0.64
6 months, n=34, 30, 35, 39
GroupValue95% CI
Placebo0.950.61 – 1.30
GSK933776 (3 mg/kg)0.880.51 – 1.25
GSK933776 (6 mg/kg)0.730.38 – 1.07
GSK933776 (15 mg/kg)0.770.44 – 1.09
12 months, n=33, 29, 34, 40
GroupValue95% CI
Placebo1.601.26 – 1.95
GSK933776 (3 mg/kg)1.811.43 – 2.18
GSK933776 (6 mg/kg)1.831.49 – 2.18
GSK933776 (15 mg/kg)1.891.57 – 2.21
18 months, n=34, 30, 32, 39
GroupValue95% CI
Placebo2.602.25 – 2.95
GSK933776 (3 mg/kg)2.772.40 – 3.14
GSK933776 (6 mg/kg)2.882.53 – 3.23
GSK933776 (15 mg/kg)2.992.67 – 3.31
Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period Primary · Up to 21 months

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. It includes:1. Any abnormal laboratory test results or other safety assessments including those that worsen from Baseline, and felt to be clinically significant in the medical and scientific judgment of the Investigator 2.Exacerbation (increase in frequency/intensity) of a chronic or intermittent pre-existing condition 3. New conditions detected or diagnosed after screening

Non-ocular AEs
GroupValue95% CI
Placebo41
GSK933776 (3 mg/kg)42
GSK933776 (6 mg/kg)44
GSK933776 (15 mg/kg)47
Ocular AEs
GroupValue95% CI
Placebo12
GSK933776 (3 mg/kg)17
GSK933776 (6 mg/kg)15
GSK933776 (15 mg/kg)20
Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period Primary · Up to 21 months
Non-ocular SAEs
GroupValue95% CI
Placebo8
GSK933776 (3 mg/kg)11
GSK933776 (6 mg/kg)9
GSK933776 (15 mg/kg)12
Ocular SAEs
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)0
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Primary · Up to 21 months

Vital signs included SBP and DBP of Potential Clinical Importance (PCI) at the indicated time points: 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 in sitting position. 'General' is an assessment time not relative to dosing. SBP was defined as: low: \<85 millimeter of mercury (mmHg) and high: \>160 mmHg and DBP was defined as: low:\<45 mmHg and high: \>100 mmHg. Only those participants available at the specified

SBP Baseline General: > CCR, n=46, 46, 48, 51
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)3
GSK933776 (6 mg/kg)2
GSK933776 (15 mg/kg)5
SBP Baseline General 2:> CCR, n=46, 46, 48, 50
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)2
GSK933776 (6 mg/kg)2
GSK933776 (15 mg/kg)4
SBP Baseline General 3:> CCR, n=45, 46, 48, 50
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)2
GSK933776 (6 mg/kg)2
GSK933776 (15 mg/kg)4
SBP Month 0, Pre-dose:> CCR, n=46, 46, 48, 51
GroupValue95% CI
Placebo2
GSK933776 (3 mg/kg)1
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)1
SBP Month 0, 0 H:> CCR, n=46, 46, 48, 51
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)1
GSK933776 (6 mg/kg)2
GSK933776 (15 mg/kg)3
SBP Month 1, Pre-dose:> CCR, n=44, 44, 44, 51
GroupValue95% CI
Placebo2
GSK933776 (3 mg/kg)5
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)2
SBP Month 1, 0 H:> CCR, n=43, 44, 44, 51
GroupValue95% CI
Placebo3
GSK933776 (3 mg/kg)2
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)2
SBP Month 2, Pre-dose:> CCR, n=44, 43, 42, 49
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)2
GSK933776 (6 mg/kg)3
GSK933776 (15 mg/kg)2
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) Primary · 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

Vital signs included HR of CCR at the indicated time points: 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 in sitting position. 'General' is an assessment time not relative to dosing. HR was defined as: low:\< 40 beats per minute (bpm) and high: \>100 bpm. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one

HR Month 3, Pre-dose:> CCR, n=44, 37, 42, 46
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)0
HR Month 13, Pre-dose:> CCR, n=38, 31, 39, 39
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)0
Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) Primary · Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit

12-lead ECG was obtained after 10 minutes rest in a supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Abnormal-clinically significant (CS) ECG measurements are presented at indicated time points: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

ECG:CS Baseline, n=46, 46, 48, 51
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)0
ECG:CS Month 6, n=41, 33, 37, 44
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)3
ECG:CS Month 12, n=41, 32, 40, 40
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)1
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)0
ECG:CS Month 18, n=38, 30, 36, 35
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)2
GSK933776 (15 mg/kg)1
ECG:CS early withdrawal, n=7, 8, 7, 3
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)1
GSK933776 (6 mg/kg)2
GSK933776 (15 mg/kg)0
ECG:CS follow-up, n=39, 37, 37, 38
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)1
Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) Primary · At any point from Baseline through follow-up visit.

The following laboratory parameters were assessed: Hematology: Platelet Count, Red Blood Cell Count, White Blood Cell (WBC) Count, Reticulocyte Count, Hemoglobin, Hematocrit, Prothrombin time-International Normalized Ratio, Activated partial thromboplastin time, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular hemoglobin concentration, Neutrophils (ANC), Lymphocytes, Monocytes, Eosinophils, and Basophils. Clinical chemistry: Blood urea nitrogen, Potassium, Aspartate aminotransferase, Total and direct bilirubin Creatinine, Chloride, Alanine aminotransferase, Uric Acid, Gl

Alanine Amino Transferase (less than PCI low)
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)0
Alanine Amino Transferase (Above PCI high)
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)1
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)0
Aspartate Amino Transferase (less than PCI low)
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)0
Aspartate Amino Transferase (Above PCI high)
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)0
Calcium (less than PCI low)
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)1
Calcium (Above PCI high)
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)1
CO2 content/Bicarbonate (less than PCI low)
GroupValue95% CI
Placebo10
GSK933776 (3 mg/kg)4
GSK933776 (6 mg/kg)9
GSK933776 (15 mg/kg)6
CO2 content/B icarbonate (AbovePCI high)
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)1
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)0
Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Primary · Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal

Magnetic Resonance Imaging (MRI) was used as a safety assessment to monitor for amyloid related imaging abnormalities (ARIA) events in the brain. MRIs were performed at Baseline and before dose 2, before dose 3, before dose 4, before dose 6, before dose 12, before dose 18 and at follow-up. ARIA-edema/effusions (ARIA-E) and ARIA hemosiderin deposition (ARIA-H) events at any visit are reported.

ARIA E
GroupValue95% CI
Placebo0
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)1
ARIA H
GroupValue95% CI
Placebo2
GSK933776 (3 mg/kg)4
GSK933776 (6 mg/kg)6
GSK933776 (15 mg/kg)4
Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye Secondary · Baseline, 6 months, 12 months and 18 months

Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence images in the study eye at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (months 6, 12,18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Screening, n=33, 30, 34, 40
GroupValue95% CI
Placebo-0.70-1.02 – -0.37
GSK933776 (3 mg/kg)-0.62-0.97 – -0.28
GSK933776 (6 mg/kg)-0.74-1.06 – -0.42
GSK933776 (15 mg/kg)-0.74-1.03 – -0.44
6 months, n=33, 30, 34, 39
GroupValue95% CI
Placebo0.810.48 – 1.13
GSK933776 (3 mg/kg)0.940.60 – 1.29
GSK933776 (6 mg/kg)0.720.40 – 1.04
GSK933776 (15 mg/kg)0.940.64 – 1.24
12 months, n=32, 29, 33, 40
GroupValue95% CI
Placebo1.331.00 – 1.67
GSK933776 (3 mg/kg)1.741.39 – 2.09
GSK933776 (6 mg/kg)1.671.34 – 1.99
GSK933776 (15 mg/kg)1.871.58 – 2.17
18 months, n=33, 30, 31, 39
GroupValue95% CI
Placebo2.241.91 – 2.57
GSK933776 (3 mg/kg)2.652.31 – 3.00
GSK933776 (6 mg/kg)2.412.08 – 2.73
GSK933776 (15 mg/kg)3.152.85 – 3.45
Change From Baseline in Area of Total hypoAF in Study Eye Secondary · Baseline, 6 months, 12 months and 18 months

Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (Month 6, 12, 18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Screening, n=33, 30, 34, 40
GroupValue95% CI
Placebo-0.65-0.95 – -0.34
GSK933776 (3 mg/kg)-0.63-0.95 – 0.31
GSK933776 (6 mg/kg)-0.71-1.01 – -0.41
GSK933776 (15 mg/kg)-1.20-1.48 – -0.92
6 months, n=33, 30, 34, 39
GroupValue95% CI
Placebo0.910.60 – 1.21
GSK933776 (3 mg/kg)1.010.69 – 1.33
GSK933776 (6 mg/kg)0.830.53 – 1.13
GSK933776 (15 mg/kg)0.840.56 – 1.13
12 months, n=32, 29, 33, 40
GroupValue95% CI
Placebo1.441.13 – 1.76
GSK933776 (3 mg/kg)1.901.57 – 2.22
GSK933776 (6 mg/kg)1.671.36 – 1.97
GSK933776 (15 mg/kg)1.641.36 – 1.92
18 months, n=33, 30, 31, 39
GroupValue95% CI
Placebo2.352.04 – 2.65
GSK933776 (3 mg/kg)2.672.35 – 2.99
GSK933776 (6 mg/kg)2.462.15 – 2.77
GSK933776 (15 mg/kg)2.852.57 – 3.13
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 Secondary · Month 12 and Month 18

Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed at the indiated time points at: Month 12 and Month 18 with categorical changes in the number of participants losing \>30, \>=15, \>=10, \>=5 and \<5 letters.

M12:Study eye, Losing > 30 letters
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)1
GSK933776 (15 mg/kg)1
M12:Study eye, Losing >= 15 letters
GroupValue95% CI
Placebo3
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)2
GSK933776 (15 mg/kg)6
M12:Study eye, Losing >= 10 letters
GroupValue95% CI
Placebo4
GSK933776 (3 mg/kg)1
GSK933776 (6 mg/kg)3
GSK933776 (15 mg/kg)9
M12:Study eye, Losing >= 5 letters
GroupValue95% CI
Placebo11
GSK933776 (3 mg/kg)7
GSK933776 (6 mg/kg)10
GSK933776 (15 mg/kg)14
M12:Study eye, Losing <5
GroupValue95% CI
Placebo28
GSK933776 (3 mg/kg)23
GSK933776 (6 mg/kg)28
GSK933776 (15 mg/kg)27
M12:fellow eye, Losing > 30 letters
GroupValue95% CI
Placebo1
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)1
M12:fellow eye, Losing >= 15 letters
GroupValue95% CI
Placebo5
GSK933776 (3 mg/kg)0
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)2
M12:fellow eye, Losing >= 10 letters
GroupValue95% CI
Placebo7
GSK933776 (3 mg/kg)3
GSK933776 (6 mg/kg)0
GSK933776 (15 mg/kg)3
Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 Secondary · Baseline and every month up to Month 18

Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed as change from baseline in the mean best-corrected ETDRS visual acuity score at 18 months. Change from Baseline is defined as post-dose visit value minus Baseline value. Note that screening occurs before baseline. Values were truncated to one decimal place and negative sign retained where value is negative and the truncated value is zero. Only those participants available at the specified time points w

Study eye, screening, n=46,46,48,48
GroupValue95% CI
Placebo0.2± 5.76
GSK933776 (3 mg/kg)2.6± 6.31
GSK933776 (6 mg/kg)0.6± 7.69
GSK933776 (15 mg/kg)0.1± 8.09
Study eye, month 1, n=44,44,44,44
GroupValue95% CI
Placebo0.7± 4.77
GSK933776 (3 mg/kg)0.3± 5.13
GSK933776 (6 mg/kg)0.4± 5.02
GSK933776 (15 mg/kg)-1.3± 5.14
Study eye, month 2, n=44,43,43,43
GroupValue95% CI
Placebo-0.3± 7.09
GSK933776 (3 mg/kg)1.0± 4.68
GSK933776 (6 mg/kg)1.2± 4.45
GSK933776 (15 mg/kg)-0.3± 6.38
Study eye, month 3, n=43,37,42,42
GroupValue95% CI
Placebo0.0± 6.57
GSK933776 (3 mg/kg)0.5± 7.53
GSK933776 (6 mg/kg)1.0± 5.86
GSK933776 (15 mg/kg)-0.0± 6.39
Study eye, month 4, n=43,36,42,42
GroupValue95% CI
Placebo0.9± 7.93
GSK933776 (3 mg/kg)1.6± 6.72
GSK933776 (6 mg/kg)0.3± 6.00
GSK933776 (15 mg/kg)-1.4± 8.09
Study eye, month 5, n=43,36,39, 39
GroupValue95% CI
Placebo-1.2± 9.03
GSK933776 (3 mg/kg)0.5± 6.60
GSK933776 (6 mg/kg)2.2± 4.88
GSK933776 (15 mg/kg)-2.6± 9.36
Study eye, month 6, n=43,36,40,40
GroupValue95% CI
Placebo-0.8± 9.90
GSK933776 (3 mg/kg)1.1± 6.91
GSK933776 (6 mg/kg)1.6± 6.55
GSK933776 (15 mg/kg)-1.0± 7.80
Study eye, month 7, n=43,36,40,40
GroupValue95% CI
Placebo0.3± 10.49
GSK933776 (3 mg/kg)1.4± 7.04
GSK933776 (6 mg/kg)1.1± 8.35
GSK933776 (15 mg/kg)-1.7± 7.71

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 21 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 9/46 (20%)
Deaths: —
GSK933776 (3 mg/kg)
Serious: 11/46 (24%)
Deaths: —
GSK933776 (6 mg/kg)
Serious: 9/48 (19%)
Deaths: —
GSK933776 (15 mg/kg)
Serious: 12/51 (24%)
Deaths: —

Serious adverse events (53 terms)

ReactionSystemPlaceboGSK933776 (3 mg/kg)GSK933776 (6 mg/kg)GSK933776 (15 mg/kg)
PneumoniaInfections and infestations————
Urinary tract infectionInfections and infestations————
Cardiac failure congestiveCardiac disorders————
vertigoEar and labyrinth disorders————
Cholecystitis infectiveInfections and infestations————
Liver abscessInfections and infestations————
Lung infectionInfections and infestations————
PharyngitisInfections and infestations————
PyelonephritisInfections and infestations————
SepsisInfections and infestations————
UrosepsisInfections and infestations————
Cerebellar infarctionNervous system disorders————
Cerebral haemorrhageNervous system disorders————
Cerebrovascular accidentNervous system disorders————
DementiaNervous system disorders————
DizzinessNervous system disorders————
Lacunar infarctionNervous system disorders————
SyncopeNervous system disorders————
Toxic encephalopathyNervous system disorders————
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Gallbladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Invasive ductal breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Metastatic squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Ovarian cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Squamous cell carcinoma of lungNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Other adverse events (42 terms — click to expand)

ReactionSystemPlaceboGSK933776 (3 mg/kg)GSK933776 (6 mg/kg)GSK933776 (15 mg/kg)
Urinary tract infectionInfections and infestations————
SinusitisInfections and infestations————
BronchitisInfections and infestations————
BlepharitisEye disorders————
Back painMusculoskeletal and connective tissue disorders————
ArthralgiaMusculoskeletal and connective tissue disorders————
Retinal haemorrhageEye disorders————
HeadacheNervous system disorders————
Oedema peripheralGeneral disorders————
NauseaGastrointestinal disorders————
DiarrhoeaGastrointestinal disorders————
ContusionInjury, poisoning and procedural complications————
FallInjury, poisoning and procedural complications————
DepressionPsychiatric disorders————
HypertensionVascular disorders————
Cardiac murmurInvestigations————
RashSkin and subcutaneous tissue disorders————
NasopharyngitisInfections and infestations————
Upper respiratory tract infectionInfections and infestations————
Visual acuity reducedEye disorders————
Vitreous detachmentEye disorders————
Macular fibrosisEye disorders————
DizzinessNervous system disorders————
Nerve compressionNervous system disorders————
ParaesthesiaNervous system disorders————
Peripheral swellingGeneral disorders————
FatigueGeneral disorders————
OedemaGeneral disorders————
PyrexiaGeneral disorders————
Pain in extremityMusculoskeletal and connective tissue disorders————
VomitingGastrointestinal disorders————
Tooth fractureInjury, poisoning and procedural complications————
Ventricular extrasystolesCardiac disorders————
Atrial fibrillationCardiac disorders————
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Squamous cell carcinoma of skinNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
InsomniaPsychiatric disorders————
CoughRespiratory, thoracic and mediastinal disorders————
Sinus congestionRespiratory, thoracic and mediastinal disorders————
AnaemiaBlood and lymphatic system disorders————

Most-reported serious reactions: Pneumonia, Urinary tract infection, Cardiac failure congestive, vertigo, Cholecystitis infective, Liver abscess, Lung infection, Pharyngitis.

Data from ClinicalTrials.gov NCT01342926 adverse events section.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ocular delivery of proteins and peptides: Challenges and novel formulation approaches.
    Mandal A, Pal D, Agrahari V, Trinh HM, et al · · 2018 · cited 159× · PMID 29339145 · DOI 10.1016/j.addr.2018.01.008
  2. Treatments for dry age-related macular degeneration: therapeutic avenues, clinical trials and future directions.
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