Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone (VITARM)
This study is ongoing, but not recruiting participants.
Sponsor:
Attila Vajas
Collaborator:
Semmelweis University
Information provided by (Responsible Party):
Attila Vajas, University of Debrecen
ClinicalTrials.gov Identifier:
NCT00931125
First received: July 1, 2009
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Retinopathy |
Drug: ranibizumab and vitrectomy Procedure: vitrectomy without preoperative ranibizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Debrecen:
Primary Outcome Measures:
- Efficacy of preoperative intravitreal ranibizumab [ Time Frame: OP day ] [ Designated as safety issue: No ]Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
Secondary Outcome Measures:
- Change in BCVA. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Effect in anatomical changes. [ Time Frame: 3 ±1 days after injection ] [ Designated as safety issue: No ]
- Safety. [ Time Frame: Over 6 months. ] [ Designated as safety issue: Yes ]
- Retinal circulation integrity. [ Time Frame: Month 1, 3, 6. ] [ Designated as safety issue: Yes ]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 )
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: vitrectomy with ranibizumab
Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
|
Drug: ranibizumab and vitrectomy
ranibizumab 10mg/ml intravitreal injection, 0,05 ml
Other Name: Lucentis intravitreal injection.
|
|
Placebo Comparator: vitrectomy without ranibizumab
Patients receiving sham treatment before vitrectomy as a comparator arm
|
Procedure: vitrectomy without preoperative ranibizumab
sham intravitreal injection before vitrectomy surgery
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931125
Locations
| Hungary | |
| University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology | |
| Debrecen, Hungary, H-4012 | |
Sponsors and Collaborators
Attila Vajas
Semmelweis University
Investigators
| Principal Investigator: | Attila Vajas, MD | National Institute of Pharmacy |
More Information
No publications provided
| Responsible Party: | Attila Vajas, MD, University of Debrecen |
| ClinicalTrials.gov Identifier: | NCT00931125 History of Changes |
| Other Study ID Numbers: | CRFB002AHU03T |
| Study First Received: | July 1, 2009 |
| Last Updated: | February 7, 2013 |
| Health Authority: | Hungary: National Institute of Pharmacy |
Keywords provided by University of Debrecen:
|
Severe proliferative diabetic retinopathy |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013