PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME (NCT03660345) | Clinical Trial Compass
CompletedPhase 3
PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
Mexico11 participantsStarted 2018-09-04
Plain-language summary
Treatment-naïve subjects with center-involved diabetic macular edema undergoing pars plana vitrectomy with internal limiting membrane peeling will have similar visual outcomes but better anatomical outcomes compared to subjects undergoing intravitreal bevacizumab monotherapy at one year.
Who can participate
Age range
20 Years – 90 Years
Sex
ALL
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
. Age ≥ 18 years
. Patient able and willing to provide informed consent
. Diagnosis of diabetes mellitus (type 1 or type 2) is established.
. Patient has non-proliferative diabetic retinopathy and is treatment-naïve for diabetic retinopathy in the study eye. (Patients may NOT have received treatment of any kind for diabetic retinopathy to the study eye).
. Best corrected visual acuity letter score is 20/32 or worse, and 20/400 or better at the time of randomization in the study eye.
. On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula is present in the study eye.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Central subfield thickness on the spectral domain OCT is greater than 300 microns at the time of randomization in the study eye.
. The study eye has no history of intraocular surgery within the previous four months. Previous uncomplicated cataract surgery otherwise shall be allowed if the study eye is longer than four months out at the time of randomization.
Exclusion criteria
. Proliferative diabetic retinopathy of any kind including neovascularization of the disc/retina/iris, presence of any degree of vitreous hemorrhage, and tractional retinal detachment must be excluded.
. Patients that received treatment to the posterior segment for any retinal condition must be excluded. Such treatments include intravitreal injections of any kind, retinal lasers of any kind, and subtenons injections.
. The study eye has a history of previous anterior or pars plana vitrectomy for any reason must be excluded.
. The patient has a history of systemic anti-VEGF therapy or systemic corticosteroid therapy within the previous 12 months.
. The patient's macular edema is considered to be due to a cause other than diabetic macular edema.
. An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, a nonretinal condition like corneal scarring or advanced optic nerve cupping from glaucoma, etc.).
. Substantial cataract that, in the opinion of the investigator, is likely decreasing visual acuity by three or more lines on its own merit (apart from the macular edema).