Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01306981
Study type	Interventional
Source	Moorfields Eye Hospital NHS Foundation Trust
Contact
Status	Completed
Phase	Phase 4
Start date	March 30, 2011
Completion date	March 12, 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms