Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:
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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 |
- Number of patients requiring pars plana vitrectomy at week 7. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 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 |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
- 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.
- Current participation in another drug or device clinical trial, or participation in such a clinical trial within the last year
- Patients unable or unwilling to give informed consent
- Patients unable or unwilling to return for follow up over 12 months
- 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| Contact: Mr Timothy Jackson, PhD FRCOphth | +44 (0)20 3299 1297 | ritidesai@nhs.net |
| United Kingdom | |
| King's College Hospital NHS Foundation Trust | Recruiting |
| London, United Kingdom, SE5 9RS | |
| Principal Investigator: Timothy Jackson, PhD FRCOphth | |
| Sub-Investigator: Robert Petrarca, MBBS | |
| Guy's & St. Thomas' Hospital NHS Foundatrion Trust | Not yet recruiting |
| London, United Kingdom, SE1 7EH | |
| Contact: Roger Wong, MD, FRCOphth | |
| Principal Investigator: Roger Wong, MD, FRCOphth | |
| Sub-Investigator: Robert Petrarca, MBBS | |
| 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 16, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by King's College Hospital NHS Trust:
|
Diabetes Vitreous Haemorrhages |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hemorrhage Vitreous Hemorrhage Diabetes Complications Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pathologic Processes Eye Hemorrhage Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013