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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04292912




Registration number
NCT04292912
Ethics application status
Date submitted
28/02/2020
Date registered
3/03/2020

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema
Scientific 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
Secondary ID [1] 0 0
212669
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK2798745

Experimental: Participants receiving GSK2798745 -


Treatment: Drugs: GSK2798745
GSK2798745 will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with abnormal ophthalmic examination findings
Timepoint [1] 0 0
Up to Day 28
Primary outcome [2] 0 0
Number of participants with abnormal refraction and visual acuity
Timepoint [2] 0 0
Up to Day 28
Primary outcome [3] 0 0
Number of participants with abnormal physical examination findings
Timepoint [3] 0 0
Up to Day 28
Primary outcome [4] 0 0
Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings
Timepoint [4] 0 0
Up to Day 28
Primary outcome [5] 0 0
Number of participants with adverse events (AE) and serious adverse events (SAE)
Timepoint [5] 0 0
Up to Day 28
Primary outcome [6] 0 0
Mean change from Baseline in center subfield retinal thickness as measured by Spectral-Domain Optical Coherence Tomography (SD-OCT)
Timepoint [6] 0 0
Baseline and at Day 28
Secondary outcome [1] 0 0
Plasma concentrations of GSK2798745
Timepoint [1] 0 0
At Day 28
Secondary outcome [2] 0 0
Plasma concentrations of major metabolite GSK3526876
Timepoint [2] 0 0
At Day 28
Secondary outcome [3] 0 0
Absorption rate of GSK2798745
Timepoint [3] 0 0
At Day 28
Secondary outcome [4] 0 0
Clearance of GSK2798745
Timepoint [4] 0 0
At Day 28
Secondary outcome [5] 0 0
Volume of distribution of GSK2798745
Timepoint [5] 0 0
At Day 28
Secondary outcome [6] 0 0
Maximum observed plasma concentration (Cmax) of GSK2798745
Timepoint [6] 0 0
At Day 28
Secondary outcome [7] 0 0
Area under concentration-time curve (AUC) over dosing interval of GSK2798745
Timepoint [7] 0 0
At Day 28

Eligibility
Key inclusion criteria
* 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.
* 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/04/2022
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Castle Hill
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2154 - Castle Hill
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04292912