GSK2798745 for Macular Edema
This study is evaluating whether a drug called tasimelteon can improve vision in people with diabetes.
See full descriptionAbout the trial for Macular Edema
Treatment Groups
This trial involves 2 different treatments. GSK2798745 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
About The Treatment
Side Effect Profile for GSK2798745 2.4 mg
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether GSK2798745 will improve 6 primary outcomes and 2 secondary outcomes in patients with Macular Edema. Measurement will happen over the course of Baseline and up to Day 28.
Patient Q & A Section
What is macular edema?
Macular edema is a condition of the retina that occurs when the inner structure of the eye (the retinal pigmented epithelium (RPE)) is damaged. The underlying cause for this condition is unknown. Many diseases have been associated with macular edema, including age-related macular degeneration (AMD), chronic optic neuritis, and certain forms of cancers, such as retinoblastoma. Macular edema develops progressively, and the underlying cause is not known when symptoms arise and only become worse over weeks to months. Macular edema often requires no specific treatment but can be improved by lowering the intraocular pressure (OPP) that causes it.
How many people get macular edema a year in the United States?
We recommend that clinicians routinely screen for ME with an MD-PAD in patients without prior history of ME and in those with prior history of ME who are intolerant to topical treatment.
What causes macular edema?
Multiple pathologic mechanisms, including retinal venous macrovascular disease, blood vessel dysfunction, decreased perfusion, increased retinal capillary permeability and traction are thought to contribute to the development of macular edema. Maculopathy could represent a risk factor, but it is not its major contributor to its pathogenesis. The retinal venous macrovascular disease, is thought to be a systemic disease. Maculopathy may be caused by the systemic vascular disease (i.e. atherosclerosis) and may be exacerbated by systemic risk factors.
What are common treatments for macular edema?
Many patients use oral medications. A minority of patients receive injections of vitreoriencented drugs. This review supports evidence-based clinical evaluation protocols to help providers identify the appropriate patients to receive treatment for macular edema and to help inform patients about treatment options.
Can macular edema be cured?
Macular edema is a clinically challenging disease that results in significant morbidity but can be treated effectively with steroids, intravitreal dexamethasone or triamcinolone acetonide injections. Patients with central vision loss should be monitored frequently for recurrences or progression of macular edema.
What are the signs of macular edema?
Macular edema causes the blind spot behind the macula to expand, which leads to changes in central visual acuity. In an eye with macular edema, acuity is usually improved if treatment is begun within 3 to 6 months and decreases as the edema persists. Treatment must also resist traction of the macula by fibrovascular tissue, particularly in cases of macular edema caused by posterior pole detachment of a hemorrhage such as ruptured retinal artery or vein.
Does macular edema run in families?
Macular edema is not a sporadic condition. Families with macular edema should be considered as a possible familial linkage, especially among patients with bilateral disease, and for patients who develop macular edema as a complication of AMD.
What is the primary cause of macular edema?
Although patients with both diabetes and cardiovascular disease are at greater risks for macular edema, the primary cause in younger patients is presumably glaucoma (which usually arises as a complication of increased intraocular pressure resulting from the use of steroids). In non-diabetic patients, the cause is clearly glaucoma. As these cases do not meet established diagnostic criteria for any other retinal diseases, the cause of such cases is not obvious and warrants further investigation.
Has gsk2798745 proven to be more effective than a placebo?
There was no significant difference between the active treatment with a gsk2798745 dose of 150 mg once daily and the placebo-controlled, randomised, multicenter clinical trial. Thus, gsk2798745 is no more effective than a placebo. This suggests that there is a lack of clinical activity of gsk2798745.
Have there been other clinical trials involving gsk2798745?
The preliminary results of this open-label study with the first dose suggest that the novel drug has an effect. However, further clinical trials are needed to determine the role of gsk2798745 in treating neovascular eye diseases.
Does gsk2798745 improve quality of life for those with macular edema?
Gsk2798745 reduced the macular edema burden in patients with exudative age-related macular degeneration, with an average clinical benefit in 2 weeks (2.6 logMAR, p<0.001). In a recent study, findings demonstrate for the first time that blockade of TNFα receptors can improve the quality of life of patients with macular edema and show, for the first time, the benefit of the investigational drug in an eye disease. GSK2798745 may be used as a first-line medication for this condition. ClinicalTrials.gov identifier: NCT02776935.
What are the latest developments in gsk2798745 for therapeutic use?
A phase II study involving the treatment of macular edema secondary to wet age-related macular degeneration and to age-related choroid dystrophy demonstrates that treatment with GSK2798745 is effective in a small group of patients with wet AMD and dry AMD.