Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre… (NCT01306981) | Clinical Trial Compass
CompletedPhase 4
Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study
United Kingdom30 participantsStarted 2011-03-30
Plain-language summary
This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery for the complications of diabetic retinopathy.
Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for patients. Our hypothesis is that injection into the eye of ranibizumab one week before surgery will make the surgery easier, reduce complications and improve outcome.
In this trial, patients will be randomly allocated to receive either ranibizumab injection or a placebo injection of saline. Neither the patient, their surgeon, nor the study investigators will know which they have received so that a fair comparison can be made.
Who can participate
Age range
18 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
. Patients of either sex aged 18 years or over
. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
. Proliferative diabetic retinopathy with complications of this requiring vitrectomy surgery with anticipated delamination of pre-retinal fibrovascular complexes
. Ability to return for study visits
. Ability to give informed consent throughout the duration of the study
Exclusion criteria
. Hypersensitivity to the active substance or to any of the excipients.
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.
What they're measuring
1
Best corrected visual acuity
Timeframe: 12 weeks post-op
Trial details
NCT IDNCT01306981
SponsorMoorfields Eye Hospital NHS Foundation Trust