Ranibizumab in Diabetic Vitrectomy (RaDiVit)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study|
- Best corrected visual acuity [ Time Frame: 12 weeks post-op ] [ Designated as safety issue: No ]
- Ease of performing vitrectomy surgery [ Time Frame: One week post injection ] [ Designated as safety issue: No ]Assessed by surgical scoring systems and counting tool usage
- Incidence of post-operative vitreous haemorrhage [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: Yes ]
- Extent of retinal neovascularisation [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: Yes ]
- Extent of tractional retinal detachment [ Time Frame: 1 week post-injection ] [ Designated as safety issue: Yes ]Assessed by serial B-scan ultrasound
- Extent of macular perfusion [ Time Frame: 12 weeks post-op ] [ Designated as safety issue: Yes ]Assessed by fundus fluorescein angiography
- Vitreous and serum levels of ranibizumab and related cytokines [ Time Frame: One week post-injection ] [ Designated as safety issue: No ]Samples to be taken on day of surgery
- Incidence of post-operative vitreous haemorrhage [ Time Frame: 12 weeks post-op ] [ Designated as safety issue: Yes ]
- Extent of retinal neovascularisation [ Time Frame: 12 weeks post-op ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Intravitreal injection of ranibizumab, 0.5mg in 0.05ml
Other Name: Lucentis
|Placebo Comparator: Saline||
Subconjunctival injection of 0.05ml saline 0.9% w/v
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306981
|Moorfields Eye Hospital|
|London, United Kingdom, EC1V 2PD|
|Principal Investigator:||James W Bainbridge, MA PhD FRCOphth||Moorfields Eye Hospital and UCL Institute of Ophthalmology Biomedical Research Centre for Ophthalmology|