a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of gsk2798745 in participants with diabetic macular edema

Conditions: Macular Edema

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 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. * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: diabetic macular edema gsk2798745 refraction visual acuity.