A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in P… (NCT03811561) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
United States1,500 participantsStarted 2019-05-08
Plain-language summary
This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus.
* HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
* Eye inclusion criteria (both eyes must meet all criteria):
* Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre
* No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.
* No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
* Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol
* No previous treatment with pan-retinal laser photocoagulation
* No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial
* No substantial media opacities that would preclude successful imaging
Exclusion Criteria:
* Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Subjects presently classified as being in New York Hear…
What they're measuring
1
Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.