Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME (NCT03690947) | Clinical Trial Compass
CompletedPhase 4
Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME
China72 participantsStarted 2018-10-01
Plain-language summary
The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.
Who can participate
Age range
30 Years – 80 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:
* Informed consent form must be signed before any tests or procedures are done
* Male or female of 30 to 80 years of age (inclusive) at the first screening visit
* Diagnosis of type 2 diabetes, with fasting blood glucose≤10mmol/L, HbA1C≤10.0%
* Diabetic medication must be stable for at least 3 months before first screening visit and remain stable during study
* Diagnosis of non-proliferative diabetic retinopathy with diabetic macular edema resulting in visual acuity reduction
* Study eye's BCVA between 24 to 78 ETDRS letters at screening and baseline of the study
* Macular edema of the study eye and central retinal thickness ≥300 µm determined by SD-OCT
* Study eye had not had grid pattern photocoagulation, intraocular surgery, intravitreal corticosteroid injections and intravitreal anti-VEGF injections for at least 3 months before baseline
* Non-study eye's BCVA ≥ 24 ETDRS letters at screening and baseline of the study
* Non-study eye had not had intravitreal anti-VEGF injections for at least 3 months before baseline
* If both eyes qualify, then investigators will choose an eye with worse BCVA as study eye. Only study eye will receive intravitreal ranibizumab and/or Micropulse Laser treatment
Exclusion Criteria:
* Failure to follow study or follow-up procedures
* Pregnant or breast-feeding woman and woman without adequate method of contraception
* History of stroke or myocardial infarction within 3 months before screening
* Renal failure or creatinine …
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.