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

NCT01306981 | Completed Phase 4 DMC

• 1 other identifier: BAIJ1006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Retinal Neovascularisation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity

  12 weeks post-op

Secondary Outcomes (8)

• Ease of performing vitrectomy surgery

  One week post injection

• Incidence of post-operative vitreous haemorrhage

  6 weeks post-op

• Extent of retinal neovascularisation

  6 weeks post-op

• Extent of tractional retinal detachment

  1 week post-injection

• Extent of macular perfusion

  12 weeks post-op

Study Arms (2)

Ranibizumab

EXPERIMENTAL

Drug: Ranibizumab

Saline

PLACEBO COMPARATOR

Drug: Saline

Interventions

Ranibizumab DRUG

Intravitreal injection of ranibizumab, 0.5mg in 0.05ml

Also known as: Lucentis

Ranibizumab

Saline DRUG

Subconjunctival injection of 0.05ml saline 0.9% w/v

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• Novartis: collaborator

Study Sites (1)

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37260074 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Retinal Neovascularization; Diabetes Mellitus; Diabetes Complications; Retinal Diseases

Interventions

Ranibizumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Endocrine System Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• James W Bainbridge, MA PhD FRCOphth

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 2, 2011
• Study Start: March 30, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 12, 2013
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

GB (1)