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Ranibizumab in Diabetic Vitrectomy (RaDiVit)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01306981
Recruitment Status : Unknown
Verified May 2011 by Moorfields Eye Hospital NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2011
Last Update Posted : February 20, 2013
Information provided by:
Moorfields Eye Hospital NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Retinal Neovascularisation Drug: Ranibizumab Drug: Saline Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study
Study Start Date : May 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 12 weeks post-op ]

Secondary Outcome Measures :
  1. Ease of performing vitrectomy surgery [ Time Frame: One week post injection ]
    Assessed by surgical scoring systems and counting tool usage

  2. Incidence of post-operative vitreous haemorrhage [ Time Frame: 6 weeks post-op ]
  3. Extent of retinal neovascularisation [ Time Frame: 6 weeks post-op ]
  4. Extent of tractional retinal detachment [ Time Frame: 1 week post-injection ]
    Assessed by serial B-scan ultrasound

  5. Extent of macular perfusion [ Time Frame: 12 weeks post-op ]
    Assessed by fundus fluorescein angiography

  6. Vitreous and serum levels of ranibizumab and related cytokines [ Time Frame: One week post-injection ]
    Samples to be taken on day of surgery

  7. Incidence of post-operative vitreous haemorrhage [ Time Frame: 12 weeks post-op ]
  8. Extent of retinal neovascularisation [ Time Frame: 12 weeks post-op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients of either sex aged 18 years or over
  2. 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)
  3. Proliferative diabetic retinopathy with complications of this requiring vitrectomy surgery with anticipated delamination of pre-retinal fibrovascular complexes
  4. Ability to return for study visits
  5. Ability to give informed consent throughout the duration of the study

Exclusion Criteria:

  1. Hypersensitivity to the active substance or to any of the excipients.
  2. Active or suspected ocular or periocular infections.
  3. Vitreous haemorrhage presumed to be caused by vitreous traction on a single, focal point of vitreoretinal attachment
  4. Cataract that, in the opinion of the investigators, would be significant enough to impair the view during surgery
  5. Active severe intraocular inflammation
  6. Previous vitrectomy surgery on study eye
  7. Vision in fellow eye 3/60 or worse
  8. Uncontrolled glaucoma
  9. History of stroke, peripheral vascular disease, angina or myocardial infarction within six months prior to randomisation
  10. Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation
  11. Pregnancy or lactation
  12. Male or female unwilling to use contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306981

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United Kingdom
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
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Principal Investigator: James W Bainbridge, MA PhD FRCOphth Moorfields Eye Hospital and UCL Institute of Ophthalmology Biomedical Research Centre for Ophthalmology
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Responsible Party: Mrs Sue Lydeard, Moorfields Eye Hospital NHS Foundation Trust Identifier: NCT01306981    
Other Study ID Numbers: BAIJ1006
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: May 2011
Keywords provided by Moorfields Eye Hospital NHS Foundation Trust:
Diabetes Mellitus
Diabetes Complications
Retinal Diseases
Endothelial Growth Factors
Monoclonal Antibodies
Vitreoretinal Surgery
Additional relevant MeSH terms:
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Diabetic Retinopathy
Retinal Neovascularization
Neovascularization, Pathologic
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathologic Processes
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents