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

Primary Purpose

Atrophy, Geographic

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GSK933776

Placebo

About this trial

This is an interventional treatment trial for Atrophy, Geographic focused on measuring age-related macular degeneration, geographic atrophy, dry AMD

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

GSK933776 3 mg/kg

GSK933776 6 mg/kg

Placebo

GSK933776 15 mg/kg

Arm Description

3 mg/kg administration of GSK933776 via intravenous infusion

6 mg/kg administration of GSK933776 via intravenous infusion

Placebo via intravenous infusion

15 mg/kg administration of GSK933776 via intravenous infusion

Outcomes

Primary Outcome Measures

Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye

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-Treat (ITT) Population who met the protocol defined inclusion criterion for area of GA assessed by color FP in the study eye in at least one visit from screening visit through BL visit, inclusive and had data of area of GA assessed by fundus autofluorescence images in the study eye for at least 75% of the visits (>=14 visits) from post-BL treatment month 2 visit to treatment month 19 visit.

Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period

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 visit 4. Signs, symptoms, or the clinical sequelae of a suspected interaction/suspected overdose of investigational product or a concomitant medication. AEs were presented as non-ocular and ocular AEs.

Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period

Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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 time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented.

Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR)

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 PCI value are presented.

Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI)

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).

Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI)

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, Glucose (fasting), Total Carbon dioxide , Gamma glutamyltransferase, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, and HbA1c. Urine: Specific gravity, pH, glucose, protein, blood and ketones and Microscopic examination. Only those with PCIs are displayed.

Number of Participants With Abnormal Magnetic Resonance Imaging (MRI)

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.

Secondary Outcome Measures

Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye

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).

Change From Baseline in Area of Total hypoAF in Study Eye

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).

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

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.

Mean Change in ETDRS-BCVA Score From Baseline at 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 were analyzed (represented by n=X, X in the category titles).

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

Area under the plasma concentration-time curve from time 0 to the end of dosing interval at steady-state; derived from dose and clearance parameters was evaluated. Blood samples were collected at the indicated time points on 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

Blood samples were collected at the indicated time points on 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

Blood samples were collected at the indicated time points on 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

Blood samples were collected at the indicated time points on 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

Blood samples were collected at the indicated time points on 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)

Blood samples were collected at the indicated time points on Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Full Information

NCT ID

NCT01342926

First Posted

April 26, 2011

Last Updated

March 27, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01342926

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

June 1, 2011 (undefined)

Primary Completion Date

April 1, 2016 (Actual)

Study Completion Date

April 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

This is a Phase 2a proof of concept study designed to evaluate the safety and efficacy of GSK933776 for the treatment of geographic atrophy secondary to age-related macular degeneration. This is a placebo-controlled parallel-group study that is double masked.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrophy, Geographic

Keywords

age-related macular degeneration, geographic atrophy, dry AMD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

191 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK933776 3 mg/kg

Arm Type

Experimental

Arm Description

3 mg/kg administration of GSK933776 via intravenous infusion

Arm Title

GSK933776 6 mg/kg

Arm Type

Experimental

Arm Description

6 mg/kg administration of GSK933776 via intravenous infusion

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo via intravenous infusion

Arm Title

GSK933776 15 mg/kg

Arm Type

Experimental

Arm Description

15 mg/kg administration of GSK933776 via intravenous infusion

Intervention Type

Drug

Intervention Name(s)

GSK933776

Intervention Description

GSK933776

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye

Description

Time Frame

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

Title

Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period

Description

Time Frame

Up to 21 months

Title

Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period

Time Frame

Up to 21 months

Title

Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Description

Time Frame

Up to 21 months

Title

Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR)

Description

Time Frame

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

Title

Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI)

Description

Time Frame

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

Title

Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI)

Description

Time Frame

At any point from Baseline through follow-up visit.

Title

Number of Participants With Abnormal Magnetic Resonance Imaging (MRI)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye

Description

Time Frame

Baseline, 6 months, 12 months and 18 months

Title

Change From Baseline in Area of Total hypoAF in Study Eye

Description

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).

Time Frame

Baseline, 6 months, 12 months and 18 months

Title

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

Description

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.

Time Frame

Month 12 and Month 18

Title

Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18

Description

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 were analyzed (represented by n=X, X in the category titles).

Time Frame

Baseline and every month up to Month 18

Title

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

Description

Time Frame

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

Title

Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants

Description

Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476

Time Frame

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

Title

Clearance (CL) of GSK933776 in Geographic Atrophy Participants

Description

Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.

Time Frame

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

Title

Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants

Description

Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.

Time Frame

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

Title

Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling

Description

Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.

Time Frame

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

Title

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)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

GSK Investigational Site

City

Arcadia

State/Province

California

ZIP/Postal Code

91007

Country

United States

Facility Name

GSK Investigational Site

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

Facility Name

GSK Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033-4500

Country

United States

Facility Name

GSK Investigational Site

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

GSK Investigational Site

City

Torrance

State/Province

California

ZIP/Postal Code

90503

Country

United States

Facility Name

GSK Investigational Site

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

GSK Investigational Site

City

Stuart

State/Province

Florida

ZIP/Postal Code

34994

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

GSK Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

GSK Investigational Site

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

GSK Investigational Site

City

Leawood

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

GSK Investigational Site

City

Prairie Village

State/Province

Kansas

ZIP/Postal Code

66208

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

Facility Name

GSK Investigational Site

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42001

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

GSK Investigational Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

GSK Investigational Site

City

Northfield

State/Province

New Jersey

ZIP/Postal Code

08225

Country

United States

Facility Name

GSK Investigational Site

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

GSK Investigational Site

City

West Mifflin

State/Province

Pennsylvania

ZIP/Postal Code

15122

Country

United States

Facility Name

GSK Investigational Site

City

Ladson

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

GSK Investigational Site

City

Galveston

State/Province

Texas

ZIP/Postal Code

77550

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

GSK Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

GSK Investigational Site

City

Silverdale

State/Province

Washington

ZIP/Postal Code

98383

Country

United States

Facility Name

GSK Investigational Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L4W 1W9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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

Atrophy, Geographic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial