Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by King's College Hospital NHS Trust
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01030770
First received: December 10, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Diabetes Complications
Drug: Ranibizumab
Drug: 0.9% Sodium Chloride
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage: A Randomized, Double-masked, Controlled Study

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Number of patients requiring pars plana vitrectomy at week 7. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients requiring pars plana vitrectomy at study end [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Mean duration from baseline to primary pars plana vitrectomy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of intraocular procedures required [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Mean ETDRS visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Surgical complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Grading of lens clarity using LOCS II (lens opacities classification system version II) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: July 2010
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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% w/v 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030770

Contacts
Contact: Mr Timothy Jackson, PhD FRCOphth +44 (0)20 3299 1297 ritidesai@nhs.net

Locations
United Kingdom
Guy's & St. Thomas' Hospital NHS Foundatrion Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Roger Wong, MD, FRCOphth         
Principal Investigator: Roger Wong, MD, FRCOphth         
Sub-Investigator: Robert Petrarca, MBBS         
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Timothy Jackson, PhD FRCOphth         
Sub-Investigator: Robert Petrarca, MBBS         
Sponsors and Collaborators
King's College Hospital NHS Trust
Novartis
Investigators
Principal Investigator: Timothy Jackson, PhD FRCOphth King's College Hospital NHS Trust
  More Information

Additional Information:
No publications provided

Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01030770     History of Changes
Other Study ID Numbers: 2009-015559-25
Study First Received: December 10, 2009
Last Updated: April 30, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by King's College Hospital NHS Trust:
Diabetes
Vitreous Haemorrhages

Additional relevant MeSH terms:
Diabetes Complications
Hemorrhage
Vitreous Hemorrhage
Diabetes Mellitus
Endocrine System Diseases
Eye Diseases
Eye Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014