- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00931125
Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone (VITARM)
October 14, 2013 updated by: Attila Vajas
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Debrecen, Hungary, H-4012
- University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: vitrectomy with ranibizumab
Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
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ranibizumab 10mg/ml intravitreal injection, 0,05 ml
Other Names:
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Placebo Comparator: vitrectomy without ranibizumab
Patients receiving sham treatment before vitrectomy as a comparator arm
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sham intravitreal injection before vitrectomy surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of preoperative intravitreal ranibizumab
Time Frame: OP day
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Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
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OP day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in BCVA.
Time Frame: 6 months
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6 months
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Effect in anatomical changes.
Time Frame: 3 ±1 days after injection
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3 ±1 days after injection
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Safety.
Time Frame: Over 6 months.
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Over 6 months.
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Retinal circulation integrity.
Time Frame: Month 1, 3, 6.
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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 )
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Month 1, 3, 6.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Attila Vajas, MD, National Institute of Pharmacy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
September 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
July 1, 2009
First Submitted That Met QC Criteria
July 1, 2009
First Posted (Estimate)
July 2, 2009
Study Record Updates
Last Update Posted (Estimate)
October 16, 2013
Last Update Submitted That Met QC Criteria
October 14, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Diabetic Retinopathy
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- CRFB002AHU03T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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