Status:
TERMINATED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema
Lead Sponsor:
GlaxoSmithKline
Conditions:
Macular Edema
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04292912
Start Date
September 7 2020
End Date
April 11 2022
Last Update
November 8 2024
Active Locations (11)
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1
GSK Investigational Site
Sacramento, California, United States, 95841
2
GSK Investigational Site
Lake Worth, Florida, United States, 33467
3
GSK Investigational Site
Winter Haven, Florida, United States, 33880
4
GSK Investigational Site
Shirley, New York, United States, 11967