CLINICAL TRIAL

GSK2798745 for Macular Edema

Recruiting · 18+ · All Sexes · McAllen, TX

This study is evaluating whether a drug called tasimelteon can improve vision in people with diabetes.

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About the trial for Macular Edema

Eligible Conditions
Macular Edema · 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
GSK2798745
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK2798745
Not yet FDA approved

Side Effect Profile for GSK2798745 2.4 mg

GSK2798745 2.4 mg
Show all side effects
9%
Fall
9%
Dermatitis contact
9%
Orthostatic hypotension
9%
Arthralgia
9%
Arthropathy
9%
Back pain
9%
Ventricular extrasystoles
9%
Lacrimation increased
9%
Chest pain
9%
Cyst
9%
Dyspnoea
9%
Ear discomfort
9%
Nausea
0%
Nightmare
0%
Dizziness
0%
Headache
0%
Neuropathy peripheral
0%
Ventricular tachycardia
0%
Visual impairment
0%
Vitreous haemorrhage
0%
Dyspnoea exertional
0%
Rhinorrhoea
0%
Hypotension
0%
Liver injury
Fall
9%
Dermatitis contact
9%
Orthostatic hypotension
9%
Arthralgia
9%
Arthropathy
9%
Back pain
9%
Ventricular extrasystoles
9%
Lacrimation increased
9%
Chest pain
9%
Cyst
9%
Dyspnoea
9%
Ear discomfort
9%
Nausea
9%
Nightmare
0%
Dizziness
0%
Headache
0%
Neuropathy peripheral
0%
Ventricular tachycardia
0%
Visual impairment
0%
Vitreous haemorrhage
0%
Dyspnoea exertional
0%
Rhinorrhoea
0%
Hypotension
0%
Liver injury
0%
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT02497937) in the GSK2798745 2.4 mg ARM group. Side effects include: Fall with 9%, Dermatitis contact with 9%, Orthostatic hypotension with 9%, Arthralgia with 9%, Arthropathy with 9%.

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Diagnosis of diabetes mellitus (type 1 or type 2).
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 40kg per square meter (inclusive) at screening.
Male participants will be eligible to participate if they agree to the following first dose of study treatment until the follow-up visit: 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 contraception/barrier as detailed below: 1. Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of less than (<)1 percent (%) per year, 2. Should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
At least 18 to 75 years of age inclusive, at the time of signing the informed consent.
Confirmation of DME with center involvement in at least one eye, including those with focal or diffuse DME as determined by Investigator-determined fluorescein angiography.
Retinal thickening (diabetic macular edema) involving the center of the fovea in the study eye as defined by Investigator-determined SD-OCT central subfield thickness greater than (>)340 microns for Heidelberg Spectralis or >320 for Zeiss Cirrus; if both eyes are eligible, the eye with the greater OCT center subfield score is selected as the study eye if all other criteria are met. SD-OCT assessments for individual patients must be taken with the same machine throughout the duration of the study.
Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) letter score of 80 letter or worse (Snellen equivalent: equivalent to 20/25) or worse in the study eye. The non-study fellow eye should equivalent or better at Baseline, pre-dose.
A female participant is eligible to participate if she is not of childbearing potential.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 7 and Day 28
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 7 and Day 28
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 7 and Day 28.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Mean change from Baseline in center subfield retinal thickness as measured by Spectral-Domain Optical Coherence Tomography (SD-OCT)
BASELINE AND UP TO DAY 28
BASELINE AND UP TO DAY 28
Number of participants with abnormal ophthalmic examination findings
AT DAY 28
AT DAY 28
Number of participants with abnormal refraction and visual acuity
AT DAY 28
AT DAY 28
Number of participants with adverse events (AE) and serious adverse events (SAE)
AT DAY 28
AT DAY 28
Number of participants with abnormal physical examination findings
AT DAY 28
AT DAY 28
Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings
AT DAY 28
AT DAY 28
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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