NCT01306981

Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study

A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Moorfields Eye Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The RaDiVit study is a pilot randomised controlled trial to evaluate the effect of ranibizumab as an adjunct to diabetic vitrectomy surgery. Patients with complications of proliferative diabetic retinopathy who require vitrectomy surgery will be recruited to this study. Baseline tests will be performed, including refracted visual acuity, B-scan ultrasound, OCT scanning, colour fundus photography and fundus fluorescein angiography. Patients will be randomised 1:1 to receive either ranibizumab intravitreal injection or saline subconjunctival injection. One week later, surgery will be carried out. The baseline tests will be repeated on the day of surgery to examine for any discernible difference between the two groups one week after treatment. Surgery will be video recorded and detailed assessments of the operative details carried out. A vitreous sample and a paired serum sample will be taken at the time of surgery to compare levels of ranibizumab and related cytokines. Follow up visits will take place at six and twelve weeks. Assessments at that point will include: * visual acuity * OCT scan * colour fundus photography and fundus fluorescein angiography

Conditions

• Diabetic Retinopathy
• Retinal Neovascularisation

Interventions

Type	Name	Description
DRUG	Ranibizumab	Intravitreal injection of ranibizumab, 0.5mg in 0.05ml
DRUG	Saline	Subconjunctival injection of 0.05ml saline 0.9% w/v

Timeline

• Start date: 2011-03-30
• Primary completion: 2013-03-01
• Completion: 2013-03-12
• First posted: 2011-03-02
• Last updated: 2020-09-09

Locations

1 site across 1 country: United Kingdom