Back to resultsSafety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone (VITARM)
Primary Purpose
Diabetic Retinopathy
Status
Unknown status
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
ranibizumab and vitrectomy
vitrectomy without preoperative ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Severe proliferative diabetic retinopathy
Eligibility Criteria
Inclusion Criteria:
- male or female 18 or older who have signed an informed consent
- Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation
- study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters
- study eye vision decrease must be resulted from severe PDR
Exclusion Criteria:
- Active ocular inflammation or infection
- History of uveitis
- Uncontrolled glaucoma
- High myopia
- Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results
- Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye
- History of vitrectomy within 60 days preceding Day 1 in the study eye
- History of intraocular surgery within 30 days preceding Day 1 in the study eye
- Untreated diabetes mellitus
- Severe hypertension (systolic pressure higher than 160mmHg)
- Current use of systemic medications known to be toxic to the retina
- History of thromboembolic events (incl MI and stroke) within 5 years
- Major surgery within previous 3 months or planned within the next 28 days
- Known coagulation abnormalities or current use of anticoagulative medications other than aspirins
- Known hypersensitivity to ranibizumab or any component of it
- Women of childbearing potential unless 2 methods of birth control applied
- Pregnant or lactating women
Sites / Locations
- University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
vitrectomy with ranibizumab
vitrectomy without ranibizumab
Arm Description
Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
Patients receiving sham treatment before vitrectomy as a comparator arm
Outcomes
Primary Outcome Measures
Efficacy of preoperative intravitreal ranibizumab
Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
Secondary Outcome Measures
Change in BCVA.
Effect in anatomical changes.
Safety.
Retinal circulation integrity.
Evaluating the circulation of original retinal vessels, evaluating the size of proliferative vessels (size of leaking areas and number of leaking points measured by Fluorescein angiography )
Full Information
NCT ID
NCT00931125
First Posted
July 1, 2009
Last Updated
October 14, 2013
Sponsor
Attila Vajas
Collaborators
Semmelweis University
1. Study Identification
Unique Protocol Identification Number
NCT00931125
Brief Title
Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
Acronym
VITARM
Official Title
Randomized, Double Blinded, Controlled, Two-center Study Assessing the Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Attila Vajas
Collaborators
Semmelweis University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.
Detailed Description
This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Severe proliferative diabetic retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vitrectomy with ranibizumab
Arm Type
Active Comparator
Arm Description
Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
Arm Title
vitrectomy without ranibizumab
Arm Type
Placebo Comparator
Arm Description
Patients receiving sham treatment before vitrectomy as a comparator arm
Intervention Type
Drug
Intervention Name(s)
ranibizumab and vitrectomy
Other Intervention Name(s)
Lucentis intravitreal injection.
Intervention Description
ranibizumab 10mg/ml intravitreal injection, 0,05 ml
Intervention Type
Procedure
Intervention Name(s)
vitrectomy without preoperative ranibizumab
Intervention Description
sham intravitreal injection before vitrectomy surgery
Primary Outcome Measure Information:
Title
Efficacy of preoperative intravitreal ranibizumab
Description
Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
Time Frame
OP day
Secondary Outcome Measure Information:
Title
Change in BCVA.
Time Frame
6 months
Title
Effect in anatomical changes.
Time Frame
3 ±1 days after injection
Title
Safety.
Time Frame
Over 6 months.
Title
Retinal circulation integrity.
Description
Evaluating the circulation of original retinal vessels, evaluating the size of proliferative vessels (size of leaking areas and number of leaking points measured by Fluorescein angiography )
Time Frame
Month 1, 3, 6.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female 18 or older who have signed an informed consent
Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation
study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters
study eye vision decrease must be resulted from severe PDR
Exclusion Criteria:
Active ocular inflammation or infection
History of uveitis
Uncontrolled glaucoma
High myopia
Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results
Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye
History of vitrectomy within 60 days preceding Day 1 in the study eye
History of intraocular surgery within 30 days preceding Day 1 in the study eye
Untreated diabetes mellitus
Severe hypertension (systolic pressure higher than 160mmHg)
Current use of systemic medications known to be toxic to the retina
History of thromboembolic events (incl MI and stroke) within 5 years
Major surgery within previous 3 months or planned within the next 28 days
Known coagulation abnormalities or current use of anticoagulative medications other than aspirins
Known hypersensitivity to ranibizumab or any component of it
Women of childbearing potential unless 2 methods of birth control applied
Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Attila Vajas, MD
Organizational Affiliation
National Institute of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
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