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

NCT ID: NCT01306981

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-30
• Study Completion Date: 2013-03-12

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

Conditions

Diabetic Retinopathy; Retinal Neovascularisation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ranibizumab

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

Intravitreal injection of ranibizumab, 0.5mg in 0.05ml

Saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Subconjunctival injection of 0.05ml saline 0.9% w/v

Interventions

Ranibizumab

Intravitreal injection of ranibizumab, 0.5mg in 0.05ml

Intervention Type: DRUG

Saline

Subconjunctival injection of 0.05ml saline 0.9% w/v

Intervention Type: DRUG

Other Intervention Names

Lucentis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James W Bainbridge, MA PhD FRCOphth

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Moorfields Eye Hospital

London, , United Kingdom

Countries

United Kingdom

References

Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.

Reference Type: DERIVED

PMID: 37260074 (View on PubMed)

Other Identifiers

BAIJ1006

Identifier Type: -

Identifier Source: org_study_id