Macular EdemaPhase 1NCT04292912
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema
A Phase 1 study testing GSK2798745 in people with Macular Edema, run by GlaxoSmithKline at 11 sites in 3 countries.
Trial summary
The study will be composed of 3 periods for all participants: Screening, 28-day Treatment period, and Follow-up visit (approximately 28 days after the final dose). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Macular Edema
- What is being tested?
- GSK2798745
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 7 Sep 2020to 11 Apr 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 to 75 years of age inclusive, at the time of signing the informed consent.
- Diagnosis of diabetes mellitus (type 1 or type 2).
- Confirmation of DME with center involvement in at least one eye by fluorescein angiography.
- Confirmation of retinal thickening (diabetic macular edema) involving the center of the fovea in the study by Investigator.
- Best Corrected Visual Acuity (BCVA) letter score of 80 letter or worse (Snellen equivalent: equivalent to 20/25) or worse in the study eye.
- Safe to withhold treatment of the study eye with laser photocoagulation, intravitreal steroid injection, or intravitreal vascular endothelial growth factor (VEGF) inhibitor for the duration of the study.
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- Body weight greater than equal to (>=) 50 kilograms (kg) and Body mass index (BMI) within the range 18 to 43 kg per square meter (inclusive) at screening.
- Male participants must agree to refrain from donating sperm, plus either be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use acceptable contraception/barrier to use acceptable contraceptive methods if their partner is of childbearing potential. This criterion must be followed from the first dose of study treatment until the follow-up visit.
- A female participant is eligible to participate if she is not of childbearing potential.
Who cannot join
- Additional eye disease in the study eye that in the opinion of the Investigator could compromise assessment.
- History of choroidal neovascularization in the study eye, or current choroidal neovascularization in the fellow eye requiring treatment.
- Active Proliferative diabetic retinopathy (PDR) in the study eye or untreated active PDR in the fellow eye.
- Ischemic maculopathy on fluorescein angiography.
- Intraocular surgery or laser photocoagulation in the study eye within 90 day.
- Use of intravitreal ranibizumab,or bevacizumab within 42 days (6 weeks), or aflibercept within 56 days (8 weeks) of dosing in the study eye.
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- Use of intraocular steroids in the study eye within 180 days of dosing.
- Use of or expected need for intravitreal or intraocular treatment in the study eye during course of the study.
- Use of any systemically administered anti-angiogenic agent within 6 months of dosing.
- Evidence of vitreomacular traction as determined by the Investigator.
- Uncontrolled intraocular pressure in the study eye despite treatment with glaucoma medication.
- Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens or optic nerve
- Uncontrolled diabetes as indicated by glycated hemoglobin (HbA1c) >12% at Screening.
- Active ulcer disease or gastrointestinal bleeding by history within 6 months of screening or by exam at the time of screening.
- Certain type of liver disease.
- Participant who, in the Investigator's opinion, poses a significant suicide risk.
- History or current evidence of any serious or clinically significant cardiac, gastrointestinal, renal, endocrine, neurologic, hematologic, infectious or other condition that is uncontrolled.
- Corrected (QTc) interval >450 milliseconds (msec) or QTc >480 msec in participants with bundle branch block.
- Use of certain medications that may interfere with the study medication or eye assessments (these will be identified by the study doctor).
- Current enrollment, or recent participation in a study of investigational intervention or medical research.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study.
- Any other reason the investigator deems the participant should not participate in the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States6 sites
GSK Investigational Site
Cincinnati, Ohio, 45202
GSK Investigational Site
Lake Worth, Florida, 33467
GSK Investigational Site
McAllen, Texas, 78503
GSK Investigational Site
Sacramento, California, 95841
GSK Investigational Site
Shirley, New York, 11967
GSK Investigational Site
Winter Haven, Florida, 33880
Australia4 sites
GSK Investigational Site
Adelaide, South Australia, 5000
GSK Investigational Site
Castle Hill, New South Wales, 2154
GSK Investigational Site
Melbourne, Victoria, 3004
GSK Investigational Site
Westmead, New South Wales, 2145
About this study
Official title: Phase I, Open-Label, Multi-Center Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of GSK2798745 After 28 Day Repeat Oral Administration to Adults With Diabetic Macular Edema
The study will be composed of 3 periods for all participants: Screening, 28-day Treatment period, and Follow-up visit (approximately 28 days after the final dose).
- Conditions
- Macular Edema
- Being tested
- GSK2798745
- Keywords
- Diabetic macular edema, GSK2798745, Refraction, Visual acuity.
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2798745Drug
GSK2798745 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| GSK2798745 | Experimental | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. Receives: Drug: GSK2798745 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abnormal Ophthalmic Examination Findings
Ophthalmic examinations for Pupil motility and confrontation visual field examination, slit lamp evaluation of anterior ocular structures, intraocular pressure measurement and optical coherence tomography (OCT) was performed on left and right eye. Participants with data including abnormalities of potential clinical importance is listed here.
Measured: Up to Day 28
Mean Change From Baseline to Day 28 in Visual Acuity
Best-correct visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. The visual function of the study eye was assessed using the ETDRS protocol. ETDRS letters score can be calculated when 20 or more letters are read correctly at 4.0 meters (m); the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m plus 30. If less than 20 letters are read correctly at 4.0 m, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m (number of letters recorded on line 1.0), plus the total number of letters read correctly at 1.0 m in the first six lines. The score ranges from 0-100 where a higher score represents better visual functioning. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Body Weight
Physical examination included the measuring of body weight and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Body Temperature
Physical examination included the measuring of body temperature and evaluated at indicated time points. The change from Baseline was calculated by subtracting Baseline value from post-Baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Vital Signs for Systolic Blood Pressure and Diastolic Blood Pressure
The change from baseline for Systolic Blood Pressure (SBP) and Diastolic blood Pressure (DBP) was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Pulse Rate
Pulse rate was measured at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in 12-lead Electrocardiogram (ECG) Findings
The 12-lead ECGs was obtained at indicated timepoints during the study. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Alanine Amino Transferase (ALT), Alkaline Phosphatase (AP), Aspartate Amino Transferase (AST), and Creatine Kinase
Summary of changes from baseline in laboratory parameters were assessed. The analysis included liver function tests for ALT, AP, AST, Creatine kinase and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Calcium, Glucose, Potassium, Sodium, and Urea Nitrogen
Summary of changes from baseline in clinical chemistry parameters. The parameters included were calcium, glucose, potassium, sodium and urea nitrogen and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Creatinine, Total Bilirubin, and Direct Bilirubin
Summary of changes from baseline in clinical chemistry parameters. The parameters analyzed were creatinine, total bilirubin and direct bilirubin and evaluated at indicated timepoints. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Clinical Chemistry Parameter Values of Protein
Summary of changes from baseline in clinical chemistry parameter, Protein. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Clinical Chemistry Parameter Values of Cardiac Troponin
Summary of changes from baseline in clinical chemistry parameters for Cardiac troponin. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelets
Summary of changes from baseline in hematology. The parameters analyzed were Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils and Platelets at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
Summary of changes from baseline in hematology. The parameters analyzed were MCHC and Hb at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Mean Corpuscular Hemoglobin
Summary of changes from baseline in mean corpuscular hemoglobin at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Mean Corpuscular Volume (MCV)
Summary of changes from baseline in hematology MCV assessment. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Erythrocytes
Summary of changes from baseline in erythrocytes at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Mean Change From Baseline to Day 28 in Hematocrit
Summary of changes from baseline in hematocrit parameter at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Ocular and Non-ocular AEs and SAEs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Data has been presented for number of participants with ocular and non-ocular AEs and SAEs.
Measured: Until follow-up (Up to Day 56)
Mean Change From Baseline to Day 28 in Center Subfield Retinal Thickness as Measured by Spectral-Domain Optical Coherence Tomography (SD-OCT)
The SD-OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of GSK2798745. The mean change from baseline in macular thickness was measured by SD-OCT in the study eye after 28 days of dosing. Measurements was obtained by an appropriately trained photographer/technician using SD-OCT equipment that has been approved by a central reader. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Measured: Baseline and Day 28
Secondary outcomes (7)
Plasma Concentrations of GSK2798745
Blood samples were collected at indicated time points for plasma concentrations of GSK2798745.
Measured: Day 7 (Pre-dose, 0.5 hour [h], 1h, 2h, 3h, 4h, 6h, 8h) and Day 28 (Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h)
Plasma Concentrations of Major Metabolite M1
Blood samples were collected at indicated time points for PK analysis of major metabolite of GSK2798745.
Measured: Day 7 (Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h) and Day 28 (Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h)
Absorption Rate of GSK2798745
Blood samples were collected at indicated time points for PK analysis of GSK2798745 absorption rate.
Measured: Day 28
Clearance of GSK2798745
Blood samples were collected at indicated time points for PK parameters including clearance of GSK2798745.
Measured: At Day 28
Volume of Distribution of GSK2798745
Blood samples were collected at indicated time points for PK parameters including volume of distribution of GSK2798745.
Measured: At Day 28
Maximum Observed Plasma Concentration (Cmax) of GSK2798745
Blood samples were collected at indicated time points for PK parameters including Cmax of GSK2798745.
Measured: At Day 28
Area Under Concentration-Time Curve (AUC) Over Dosing Interval of GSK2798745
Blood samples were collected at indicated time points for PK parameters including AUC of GSK2798745.
Measured: At Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start7 Sep 2020
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Why it stopped: The study was terminated as the study met the prespecified threshold for futility of less than (\<) 20 percentage (%), based on interim analysis (IA).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-center, open-label, single arm study.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292912
- Sponsor's protocol ID
- 212669
- Status last verified
- Aug 2024
- First submitted
- 28 Feb 2020
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label, Multi-Center Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of GSK2798745 After 28 Day Repeat Oral Administration to Adults With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT04292912
- Acronym / sponsor ID
- 212669
- Conditions
- Macular Edema
- Keywords
- Diabetic macular edema, GSK2798745, Refraction, Visual acuity.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated as the study met the prespecified threshold for futility of less than (\<) 20 percentage (%), based on interim analysis (IA).
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be composed of 3 periods for all participants: Screening, 28-day Treatment period, and Follow-up visit (approximately 28 days after the final dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-center, open-label, single arm study.
| Arm | Type | Receives |
|---|---|---|
| GSK2798745 | Experimental | Drug: GSK2798745Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 to 75 years of age inclusive, at the time of signing the informed consent.
- Diagnosis of diabetes mellitus (type 1 or type 2).
- Confirmation of DME with center involvement in at least one eye by fluorescein angiography.
- Confirmation of retinal thickening (diabetic macular edema) involving the center of the fovea in the study by Investigator.
- Best Corrected Visual Acuity (BCVA) letter score of 80 letter or worse (Snellen equivalent: equivalent to 20/25) or worse in the study eye.
Key exclusion criteria (23 listed)
- Additional eye disease in the study eye that in the opinion of the Investigator could compromise assessment.
- History of choroidal neovascularization in the study eye, or current choroidal neovascularization in the fellow eye requiring treatment.
- Active Proliferative diabetic retinopathy (PDR) in the study eye or untreated active PDR in the fellow eye.
- Ischemic maculopathy on fluorescein angiography.
- Intraocular surgery or laser photocoagulation in the study eye within 90 day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK2798745GSK2798745 will be administered. | Drug | GSK2798745 |
Primary outcome
Number of Participants With Abnormal Ophthalmic Examination Findings
Time frame: Up to Day 28
Ophthalmic examinations for Pupil motility and confrontation visual field examination, slit lamp evaluation of anterior ocular structures, intraocular pressure measurement and optical coherence tomography (OCT) was performed on left and right eye. Participants with data including abnormalities of potential clinical importance is listed here.
Mean Change From Baseline to Day 28 in Visual Acuity
Time frame: Baseline and Day 28
Best-correct visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. The visual function of the study eye was assessed using the ETDRS protocol. ETDRS letters score can be calculated when 20 or more letters are read correctly at 4.0 meters (m); the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m plus 30. If less than 20 letters are read correctly at 4.0 m, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m (number of letters recorded on line 1.0), plus the total number of letters read correctly at 1.0 m in the first six lines. The score ranges from 0-100 where a higher score represents better visual functioning. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Body Weight
Time frame: Baseline and Day 28
Physical examination included the measuring of body weight and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Body Temperature
Time frame: Baseline and Day 28
Physical examination included the measuring of body temperature and evaluated at indicated time points. The change from Baseline was calculated by subtracting Baseline value from post-Baseline value.
Mean Change From Baseline to Day 28 in Vital Signs for Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: Baseline and Day 28
The change from baseline for Systolic Blood Pressure (SBP) and Diastolic blood Pressure (DBP) was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Pulse Rate
Time frame: Baseline and Day 28
Pulse rate was measured at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in 12-lead Electrocardiogram (ECG) Findings
Time frame: Baseline and Day 28
The 12-lead ECGs was obtained at indicated timepoints during the study. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Alanine Amino Transferase (ALT), Alkaline Phosphatase (AP), Aspartate Amino Transferase (AST), and Creatine Kinase
Time frame: Baseline and Day 28
Summary of changes from baseline in laboratory parameters were assessed. The analysis included liver function tests for ALT, AP, AST, Creatine kinase and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Calcium, Glucose, Potassium, Sodium, and Urea Nitrogen
Time frame: Baseline and Day 28
Summary of changes from baseline in clinical chemistry parameters. The parameters included were calcium, glucose, potassium, sodium and urea nitrogen and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Creatinine, Total Bilirubin, and Direct Bilirubin
Time frame: Baseline and Day 28
Summary of changes from baseline in clinical chemistry parameters. The parameters analyzed were creatinine, total bilirubin and direct bilirubin and evaluated at indicated timepoints. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Clinical Chemistry Parameter Values of Protein
Time frame: Baseline and Day 28
Summary of changes from baseline in clinical chemistry parameter, Protein. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Clinical Chemistry Parameter Values of Cardiac Troponin
Time frame: Baseline and Day 28
Summary of changes from baseline in clinical chemistry parameters for Cardiac troponin. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelets
Time frame: Baseline and Day 28
Summary of changes from baseline in hematology. The parameters analyzed were Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils and Platelets at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
Time frame: Baseline and Day 28
Summary of changes from baseline in hematology. The parameters analyzed were MCHC and Hb at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Mean Corpuscular Hemoglobin
Time frame: Baseline and Day 28
Summary of changes from baseline in mean corpuscular hemoglobin at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Mean Corpuscular Volume (MCV)
Time frame: Baseline and Day 28
Summary of changes from baseline in hematology MCV assessment. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Erythrocytes
Time frame: Baseline and Day 28
Summary of changes from baseline in erythrocytes at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Mean Change From Baseline to Day 28 in Hematocrit
Time frame: Baseline and Day 28
Summary of changes from baseline in hematocrit parameter at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Ocular and Non-ocular AEs and SAEs
Time frame: Until follow-up (Up to Day 56)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Data has been presented for number of participants with ocular and non-ocular AEs and SAEs.
Mean Change From Baseline to Day 28 in Center Subfield Retinal Thickness as Measured by Spectral-Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline and Day 28
The SD-OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of GSK2798745. The mean change from baseline in macular thickness was measured by SD-OCT in the study eye after 28 days of dosing. Measurements was obtained by an appropriately trained photographer/technician using SD-OCT equipment that has been approved by a central reader. The change from baseline was calculated by subtracting baseline value from post-baseline value.
7 secondary outcomes
Plasma Concentrations of GSK2798745
Time frame: Day 7 (Pre-dose, 0.5 hour [h], 1h, 2h, 3h, 4h, 6h, 8h) and Day 28 (Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h)
Plasma Concentrations of Major Metabolite M1
Time frame: Day 7 (Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h) and Day 28 (Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h)
Absorption Rate of GSK2798745
Time frame: Day 28
Clearance of GSK2798745
Time frame: At Day 28
Volume of Distribution of GSK2798745
Time frame: At Day 28
Maximum Observed Plasma Concentration (Cmax) of GSK2798745
Time frame: At Day 28
Area Under Concentration-Time Curve (AUC) Over Dosing Interval of GSK2798745
Time frame: At Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2798745 in people with Macular Edema, run by GlaxoSmithKline at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Abnormal Ophthalmic Examination Findings (time frame: Up to Day 28). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.