Working… Menu

Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01030770
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : July 27, 2018
Information provided by (Responsible Party):
King's College Hospital NHS Trust

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.

Condition or disease Intervention/treatment Phase
Diabetes Complications Drug: Ranibizumab Drug: 0.9% Sodium Chloride Phase 2 Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage: A Randomized, Double-masked, Controlled Study
Study Start Date : July 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm A (treatment)
Arm A: Single intravitreal injection of 500 micrograms of ranibizumab (0.05mls) (Lucentis®)
Drug: Ranibizumab
Single intravitreal injection of 500 micrograms of ranibizumab (0.05mls).
Other Name: Lucentis®

Placebo Comparator: Arm B (control):
Arm B: Single subconjunctival injection of 0.05mls of 0.9% sodium chloride (Minims Saline®)
Drug: 0.9% Sodium Chloride
Single subconjunctival injection of 0.05mls of 0.9% w/v sodium chloride
Other Name: Normal Saline

Primary Outcome Measures :
  1. Number of patients requiring pars plana vitrectomy at week 7. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of patients requiring pars plana vitrectomy at study end [ Time Frame: 12 months ]
  2. Mean duration from baseline to primary pars plana vitrectomy [ Time Frame: 12 months ]
  3. Number of intraocular procedures required [ Time Frame: 12 months ]
  4. Mean ETDRS visual acuity [ Time Frame: 12 months ]
  5. 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 [ Time Frame: 12 months ]
  6. Surgical complications [ Time Frame: 12 months ]
  7. Grading of lens clarity using LOCS II (lens opacities classification system version II) [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. The presence of tractional retinal elevation in the study eye, as detected by B mode ocular ultrasound or fundus biomicroscopy.
  2. Other (non-diabetic) cause of vitreous haemorrhage
  3. Other (non-diabetic) retinal vasculopathy in the study eye
  4. Subjects who were listed for vitrectomy for recurrent vitreous haemorrhage alone, and not for persistent vitreous haemorrhage
  5. Subjects whose planned vitrectomy was to have been combined with cataract surgery
  6. Prior vitrectomy in the study eye
  7. Visual acuity worse than 6/96 in the non study eye
  8. Aphakia in the study eye
  9. Pregnant (urine dipstick confirmed) or lactating women (women of childbearing potential should be advised to use appropriate contraception for three months following eye injection
  10. Those with systemic or ocular contraindications to ranibizumab therapy
  11. Sickle cell disease. Those with sickle trait may be included if there is no evidence of retinopathy in the non study eye.
  12. Patients who have had an intravitreal injection of any therapeutic agent in the study eye
  13. Subjects with active concomitant disease in the study eye, including uveitis and infection
  14. Subjects with inadequate pupil dilation in the study eye, or other cause of significantly impaired fundus view
  15. Subjects with potentially visually significant cataract in the study eye
  16. Subjects who have undergone intraocular surgery in the study eye less than 6 months prior to screening with the exception of cataract surgery, which must have been at least 2 months prior to screening
  17. Subjects who have commenced medications that target haemostasis within 3 months of screening, including antithrombotic, antiplatelet and anticoagulant therapy, or who are likely to commence or alter such medications during the course of the study. Subjects who have commenced treatment with these agents at least 3 months prior to screening, and who are stable on treatment, are eligible for inclusion.
  18. Current participation in another drug or device clinical trial, or participation in such a clinical trial within the last year
  19. Patients unable or unwilling to give informed consent
  20. Patients unable or unwilling to return for follow up over 12 months
  21. Any other condition or situation that, in the opinion of the investigator, may prevent the patient from complying with the study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030770

Layout table for location information
United Kingdom
Guy's & St. Thomas' Hospital NHS Foundatrion Trust
London, United Kingdom, SE1 7EH
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Layout table for investigator information
Principal Investigator: Timothy Jackson, PhD FRCOphth King's College Hospital NHS Trust

Additional Information:
Layout table for additonal information
Responsible Party: King's College Hospital NHS Trust Identifier: NCT01030770     History of Changes
Other Study ID Numbers: 2009-015559-25
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by King's College Hospital NHS Trust:
Vitreous Haemorrhages
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitreous Hemorrhage
Diabetes Complications
Pathologic Processes
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents