Ranibizumab in Diabetic Vitrectomy (RaDiVit)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Retinopathy Retinal Neovascularisation |
Drug: Ranibizumab Drug: Saline |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 30 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ranibizumab |
Drug: Ranibizumab
Intravitreal injection of ranibizumab, 0.5mg in 0.05ml
Other Name: Lucentis
|
| Placebo Comparator: Saline |
Drug: Saline
Subconjunctival injection of 0.05ml saline 0.9% w/v
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes
- Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for Diagnosis of Diabetes)
- 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
- Active severe intraocular inflammation
- Previous vitrectomy surgery on study eye
- Vision in fellow eye 3/60 or worse
- Uncontrolled glaucoma
- History of stroke, peripheral vascular disease, angina or myocardial infarction within six months prior to randomisation
- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation
- Pregnancy or lactation
- Male or female unwilling to use contraception
Contacts and Locations| United Kingdom | |
| 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 |
More Information
No publications provided
| Responsible Party: | Mrs Sue Lydeard, Moorfields Eye Hospital NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01306981 History of Changes |
| Other Study ID Numbers: | BAIJ1006 |
| Study First Received: | March 1, 2011 |
| Last Updated: | February 19, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee |
Keywords provided by Moorfields Eye Hospital NHS Foundation Trust:
|
Diabetes Mellitus Diabetes Complications Retinal Diseases Endothelial Growth Factors |
Monoclonal Antibodies Ranibizumab Vitrectomy Vitreoretinal Surgery |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Neovascularization, Pathologic Retinal Diseases Retinal Neovascularization Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Metaplasia Pathologic Processes Endothelial Growth Factors Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013