A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema

NCT ID: NCT04292912

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2022-04-11

Brief 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).

Conditions

Macular Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GSK2798745

Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day.

Group Type: EXPERIMENTAL

GSK2798745

Intervention Type: DRUG

GSK2798745 will be administered.

Interventions

GSK2798745

GSK2798745 will be administered.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Lake Worth, Florida, United States

GSK Investigational Site

Winter Haven, Florida, United States

GSK Investigational Site

Shirley, New York, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

McAllen, Texas, United States

GSK Investigational Site

Castle Hill, New South Wales, Australia

GSK Investigational Site

Westmead, New South Wales, Australia

GSK Investigational Site

Adelaide, South Australia, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Christchurch, , New Zealand

Countries

United States; Australia; New Zealand

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

212669

Identifier Type: -

Identifier Source: org_study_id