Status:
COMPLETED
Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Vitreous Hemorrhage
Proliferative Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study is being conducted to determine if intravitreal injections of ranibizumab decrease the proportion of eyes in which vitrectomy is performed compared with saline injections in eyes presenting...
Detailed Description
In mild to moderate cases of vitreous hemorrhage, panretinal photocoagulation (PRP) is performed when possible to achieve regression of new vessels or at least stabilization of the neovascularization ...
Eligibility Criteria
Inclusion
- Subject-level Criteria
- Inclusion
- To be eligible, the following inclusion criteria must be met:
- Age \>= 18 years Diagnosis of diabetes mellitus (type 1 or type 2) At least one eye meets the study eye criteria listed below Able and willing to provide informed consent.
- Exclusion
- A subject is not eligible if any of the following exclusion criteria are present:
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- A condition that, in the opinion of the investigator, would preclude subject undergoing elective vitrectomy surgery if indicated during the study.
- Participation in an investigational trial that involved treatment with any drug within 30 days of randomization that has not received regulatory approval at the time of study entry.
- Known allergy to any component of the study drug. Blood pressure \> 180/110 (systolic above 180 or diastolic above 110). Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 4 months.
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study.
- Study Eye Criteria
- The subject must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.
- A subject can have only one study eye. If both eyes are eligible at the time of randomization, the study eye will be selected by the investigator and subject before randomization.
- The eligibility criteria for a study eye are as follows:
- Inclusion
- Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, and precluding completion of panretinal photocoagulation (or precluding assessment of completeness of prior PRP).
- Immediate vitrectomy not required (investigator and subject are willing to wait at least 8 weeks to see if hemorrhage clears sufficiently without having to proceed to vitrectomy).
- Visual acuity is light perception or better.
- Exclusion
- Prompt vitrectomy indicated, such as because of signs of rhegmatogenous retinal detachment or traction detachment involving the macula present on ultrasound.
- Exam evidence of neovascular glaucoma, angle neovascularization, or active neovascularization of the iris (small iris tufts not an exclusion).
- History of intravitreal anti-VEGF treatment for vitreous hemorrhage at any time in the past or for an indication other than vitreous hemorrhage in the past 2 months.
- History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months following randomization.
- History of vitrectomy. History of yttrium aluminum garnet capsulotomy performed within 2 months prior to randomization.
- Aphakia. Uncontrolled glaucoma (in investigator's judgment). Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00996437
Start Date
June 1 2010
End Date
January 1 2013
Last Update
August 26 2016
Active Locations (67)
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1
Retinal Consultants of AZ
Phoenix, Arizona, United States, 85014
2
University of California, Irvine
Irvine, California, United States, 92697
3
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States, 92354
4
Southern California Desert Retina Consultants, MC
Palm Springs, California, United States, 92262