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 range18 Years
SexALL
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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.
✕. Active or suspected ocular or periocular infections.
✕. Vitreous haemorrhage presumed to be caused by vitreous traction on a single, focal point of vitreoretinal attachment
✕. Cataract that, in the opinion of the investigators, would be significant enough to impair the view during surgery
What they're measuring
1
Best corrected visual acuity
Timeframe: 12 weeks post-op
Trial details
NCT IDNCT01306981
SponsorMoorfields Eye Hospital NHS Foundation Trust