Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N) (N)
Vitreous Hemorrhage, Proliferative Diabetic Retinopathy
About this trial
This is an interventional treatment trial for Vitreous Hemorrhage focused on measuring vitreous, hemorrhage, proliferative, diabetic, retinopathy, intravitreal, ranibizumab, Lucentis, saline, vitrectomy
Eligibility Criteria
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.
Sites / Locations
- Retinal Consultants of AZ
- University of California, Irvine
- Loma Linda University Health Care, Dept. of Ophthalmology
- Southern California Desert Retina Consultants, MC
- Bay Area Retina Associates
- Retinal Consultants of Southern California Medical Group, Inc.
- Denver Health Medical Center
- New England Retina Associates, PC
- The George Washington University, Department of Ophthalmology
- Retina Consultants of Southwest Florida
- University of Florida College of Med., Department of Ophthalmology
- Florida Retina Consultants
- Magruder Eye Institute
- Sarasota Retina Institute
- Retina Associates of Sarasota
- Emory Eye Center
- Georgia Retina, P.C.
- Southeast Retina Center, P.C.
- Retina Associates of Hawaii, Inc.
- University of Illinois at Chicago Medical Center
- Raj K. Maturi, M.D., P.C.
- American Eye Institute
- Medical Associates Clinic, P.C.
- Wolfe Eye Clinic
- Sabates Eye Centers Research Division
- Retina and Vitreous Associates of Kentucky
- Paducah Retinal Center
- Elman Retina Group, P.A.
- Wilmer Eye Institute at Johns Hopkins
- Wilmer Eye Institute at Johns Hopkins
- Retina Consultants of Delmarva, P.A.
- Joslin Diabetes Center
- Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
- Vitreo-Retinal Associates
- Retina Center, PA
- Barnes Retina Institute
- Delaware Valley Retina Associates
- The New York Eye and Ear Infirmary/Faculty Eye Practice
- Mount Sinai School of Medicine, Dept. of Ophthalmology
- Retina Consultants of Western New York
- Eye Care for the Adirondacks
- Retina-Vitreous Surgeons of Central New York, PC
- University of North Carolina, Dept of Ophthalmology
- Charlotte Eye Ear Nose and Throat Assoc, PA
- Piedmont Retina Specialists, PA
- Mid-America Retina Consultants, P.A.
- Wake Forest University Eye Center
- Retina Associates of Cleveland, Inc.
- Case Western Reserve University
- OSU Eye Physicians and Surgeons, LLC.
- Retina Northwest, PC
- Family Eye Group
- University of Pennsylvania Scheie Eye Institute
- Carolina Retina Center
- Southeastern Retina Associates, PC
- Southeastern Retina Associates, P.C.
- West Texas Retina Consultants P.A.
- Retina Research Center
- Retina and Vitreous of Texas
- Baylor Eye Physicians and Surgeons
- Texas Retina Associates
- Valley Retina Institute
- Medical Center Ophthalmology Associates
- Retinal Consultants of San Antonio
- Virginia Retina Center
- University of Washington Medical Center
- Medical College of Wiconsin
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Saline Injection
Ranibizumab
Saline injection at baseline, 4 and 8 weeks
Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks