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

Primary Purpose

Diabetic Retinopathy, Retinal Neovascularisation

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Ranibizumab

Saline

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetes Mellitus, Diabetes Complications, Retinal Diseases, Endothelial Growth Factors, Monoclonal Antibodies, Ranibizumab, Vitrectomy, Vitreoretinal Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ranibizumab

Saline

Arm Description

Outcomes

Primary Outcome Measures

Best corrected visual acuity

Secondary Outcome Measures

Ease of performing vitrectomy surgery

Assessed by surgical scoring systems and counting tool usage

Incidence of post-operative vitreous haemorrhage

Extent of retinal neovascularisation

Extent of tractional retinal detachment

Assessed by serial B-scan ultrasound

Extent of macular perfusion

Assessed by fundus fluorescein angiography

Vitreous and serum levels of ranibizumab and related cytokines

Samples to be taken on day of surgery

Incidence of post-operative vitreous haemorrhage

Extent of retinal neovascularisation

Full Information

NCT ID

NCT01306981

First Posted

March 1, 2011

Last Updated

September 7, 2020

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT01306981

Brief Title

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

Acronym

RaDiVit

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

March 30, 2011 (Actual)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 12, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy, Retinal Neovascularisation

Keywords

Diabetes Mellitus, Diabetes Complications, Retinal Diseases, Endothelial Growth Factors, Monoclonal Antibodies, Ranibizumab, Vitrectomy, Vitreoretinal Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab

Arm Type

Experimental

Arm Title

Saline

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

Intravitreal injection of ranibizumab, 0.5mg in 0.05ml

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

Subconjunctival injection of 0.05ml saline 0.9% w/v

Primary Outcome Measure Information:

Title

Best corrected visual acuity

Time Frame

12 weeks post-op

Secondary Outcome Measure Information:

Title

Ease of performing vitrectomy surgery

Description

Assessed by surgical scoring systems and counting tool usage

Time Frame

One week post injection

Title

Incidence of post-operative vitreous haemorrhage

Time Frame

6 weeks post-op

Title

Extent of retinal neovascularisation

Time Frame

6 weeks post-op

Title

Extent of tractional retinal detachment

Description

Assessed by serial B-scan ultrasound

Time Frame

1 week post-injection

Title

Extent of macular perfusion

Description

Assessed by fundus fluorescein angiography

Time Frame

12 weeks post-op

Title

Vitreous and serum levels of ranibizumab and related cytokines

Description

Samples to be taken on day of surgery

Time Frame

One week post-injection

Title

Incidence of post-operative vitreous haemorrhage

Time Frame

12 weeks post-op

Title

Extent of retinal neovascularisation

Time Frame

12 weeks post-op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James W Bainbridge, MA PhD FRCOphth

Organizational Affiliation

Moorfields Eye Hospital and UCL Institute of Ophthalmology Biomedical Research Centre for Ophthalmology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Moorfields Eye Hospital

City

London

ZIP/Postal Code

EC1V 2PD

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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