Ranibizumab in Diabetic Vitrectomy (RaDiVit)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Moorfields Eye Hospital NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01306981
First received: March 1, 2011
Last updated: February 19, 2013
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by Moorfields Eye Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 12 weeks post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306981

Locations
United Kingdom
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Novartis
Investigators
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 July 31, 2014