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

September 7, 2020 updated by: Moorfields Eye Hospital NHS Foundation Trust

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Saline
Drug: Saline
Subconjunctival injection of 0.05ml saline 0.9% w/v
EXPERIMENTAL: Ranibizumab
Drug: Ranibizumab
Intravitreal injection of ranibizumab, 0.5mg in 0.05ml
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best corrected visual acuity
Time Frame: 12 weeks post-op
12 weeks post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of performing vitrectomy surgery
Time Frame: One week post injection
Assessed by surgical scoring systems and counting tool usage
One week post injection
Incidence of post-operative vitreous haemorrhage
Time Frame: 6 weeks post-op
6 weeks post-op
Extent of retinal neovascularisation
Time Frame: 6 weeks post-op
6 weeks post-op
Extent of tractional retinal detachment
Time Frame: 1 week post-injection
Assessed by serial B-scan ultrasound
1 week post-injection
Extent of macular perfusion
Time Frame: 12 weeks post-op
Assessed by fundus fluorescein angiography
12 weeks post-op
Vitreous and serum levels of ranibizumab and related cytokines
Time Frame: One week post-injection
Samples to be taken on day of surgery
One week post-injection
Incidence of post-operative vitreous haemorrhage
Time Frame: 12 weeks post-op
12 weeks post-op
Extent of retinal neovascularisation
Time Frame: 12 weeks post-op
12 weeks post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Collaborators

Novartis

Investigators

  • Principal Investigator: James W Bainbridge, MA PhD FRCOphth, Moorfields Eye Hospital and UCL Institute of Ophthalmology Biomedical Research Centre for Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2011

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 12, 2013

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (ESTIMATE)

March 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAIJ1006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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