Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:

NCT01030770 | Completed Phase 2

• 1 other identifier: 2009-015559-25
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

This study will enrol patients with diabetes who have already elected to undergo pars plana vitrectomy (eye surgery) to remove persistent vitreous haemorrhage (a complication of severe diabetic eye disease in which blood fills the inner cavity of the eye, obscuring the vision and preventing treatment to stop the bleeding). Those in the treatment arm will have an intravitreal injection of ranibizumab (Lucentis) at the same dose used for the treatment of neovascular (wet) age-related macular degeneration (a disease that has some features in common with diabetic eye disease). It is hypothesised that this will promote clearance of the vitreous haemorrhage and that this, in turn, may mean that some patients do not need to proceed to vitrectomy.

Conditions

Diabetes Complications

Keywords

Diabetes; Vitreous Haemorrhages

Outcome Measures

Primary Outcomes (1)

• Number of patients requiring pars plana vitrectomy at week 7.

  12 months

Secondary Outcomes (7)

• Number of patients requiring pars plana vitrectomy at study end

  12 months

• Mean duration from baseline to primary pars plana vitrectomy

  12 months

• Number of intraocular procedures required

  12 months

• Mean ETDRS visual acuity

  12 months

• Mean grade of vitreous haemorrhage (Grade 0-4) assessed using masked independent reading of fundus photographs, at 6 weeks after the Lucentis or placebo injection

  12 months

Study Arms (2)

Arm A (treatment)

EXPERIMENTAL

Arm A: Single intravitreal injection of 500 micrograms of ranibizumab (0.05mls) (Lucentis®)

Drug: Ranibizumab

Arm B (control):

PLACEBO COMPARATOR

Arm B: Single subconjunctival injection of 0.05mls of 0.9% sodium chloride (Minims Saline®)

Drug: 0.9% Sodium Chloride

Interventions

Ranibizumab DRUG

Single intravitreal injection of 500 micrograms of ranibizumab (0.05mls).

Also known as: Lucentis®

Arm A (treatment)

0.9% Sodium Chloride DRUG

Single subconjunctival injection of 0.05mls of 0.9% w/v sodium chloride

Also known as: Normal Saline

Arm B (control):

Eligibility Criteria

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

You may qualify if:

• Adults (male or female over 18) with Type 1 or Type 2 diabetes mellitus
• Grade 2-4 fundus obscuring diabetic vitreous haemorrhage of at least 2 months duration prior to screening in the study eye.
• Subjects who have elected to undergo a therapeutic pars plana vitrectomy to clear persistent diabetic vitreous haemorrhage
• Best corrected visual acuity from 40 letters (using 4 metre ETDRS visual acuity score) to perception of light in the study eye
• Patients able and willing to give written and witnessed informed consent.

You may not qualify if:

• The presence of tractional retinal elevation in the study eye, as detected by B mode ocular ultrasound or fundus biomicroscopy.
• Other (non-diabetic) cause of vitreous haemorrhage
• Other (non-diabetic) retinal vasculopathy in the study eye
• Subjects who were listed for vitrectomy for recurrent vitreous haemorrhage alone, and not for persistent vitreous haemorrhage
• Subjects whose planned vitrectomy was to have been combined with cataract surgery
• Prior vitrectomy in the study eye
• Visual acuity worse than 6/96 in the non study eye
• Aphakia in the study eye
• Pregnant (urine dipstick confirmed) or lactating women (women of childbearing potential should be advised to use appropriate contraception for three months following eye injection
• Those with systemic or ocular contraindications to ranibizumab therapy
• Sickle cell disease. Those with sickle trait may be included if there is no evidence of retinopathy in the non study eye.
• Patients who have had an intravitreal injection of any therapeutic agent in the study eye
• Subjects with active concomitant disease in the study eye, including uveitis and infection
• Subjects with inadequate pupil dilation in the study eye, or other cause of significantly impaired fundus view
• Subjects with potentially visually significant cataract in the study eye

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Novartis: collaborator

Study Sites (2)

Guy's & St. Thomas' Hospital NHS Foundatrion Trust

London, SE1 7EH, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Links

• Website for King's College Hospital (Study Sponsor Site)

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus

Interventions

Ranibizumab; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Endocrine System Diseases; 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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Timothy Jackson, PhD FRCOphth

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: July 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: July 27, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)