Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)
N
An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy
3 other identifiers
interventional
261
1 country
67
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 with vitreous hemorrhage from proliferative diabetic retinopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2010
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2009
CompletedFirst Posted
Study publicly available on registry
October 16, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
May 16, 2013
CompletedAugust 26, 2016
August 1, 2016
1.7 years
October 14, 2009
February 19, 2013
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Treatment or "Failure" Defined as Vitrectomy
The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.
within 112 days of randomization
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Baseline to 16 weeks
Secondary Outcomes (6)
Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy
within 112 days of randomization
Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength
4, 8 and 12 weeks
Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status
4, 8 and 12 weeks
Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit
4, 8 and 12 weeks
Severe Visual Acuity Loss (Defined as <20/200)
4,8 and 12 weeks
- +1 more secondary outcomes
Study Arms (2)
Saline Injection
PLACEBO COMPARATORSaline injection at baseline, 4 and 8 weeks
Ranibizumab
ACTIVE COMPARATORIntravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
Interventions
Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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:
- 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.
- Prompt vitrectomy indicated, such as because of signs of rhegmatogenous retinal detachment or traction detachment involving the macula present on ultrasound.
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jaeb Center for Health Researchlead
- National Eye Institute (NEI)collaborator
Study Sites (67)
Retinal Consultants of AZ
Phoenix, Arizona, 85014, United States
University of California, Irvine
Irvine, California, 92697, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, 92354, United States
Southern California Desert Retina Consultants, MC
Palm Springs, California, 92262, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Retinal Consultants of Southern California Medical Group, Inc.
Westlake Village, California, 91361, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
New England Retina Associates, PC
Trumbull, Connecticut, 06611, United States
The George Washington University, Department of Ophthalmology
Washington D.C., District of Columbia, 20037, United States
Retina Consultants of Southwest Florida
Fort Myers, Florida, 33912, United States
University of Florida College of Med., Department of Ophthalmology
Jacksonville, Florida, 32209, United States
Florida Retina Consultants
Lakeland, Florida, 33805, United States
Magruder Eye Institute
Orlando, Florida, 32803, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
Retina Associates of Sarasota
Venice, Florida, 34285, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
Georgia Retina, P.C.
Atlanta, Georgia, 30342, United States
Southeast Retina Center, P.C.
Augusta, Georgia, 30909, United States
Retina Associates of Hawaii, Inc.
Honolulu, Hawaii, 96813, United States
University of Illinois at Chicago Medical Center
Chicago, Illinois, 60612, United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, 46290, United States
American Eye Institute
New Albany, Indiana, 47150, United States
Medical Associates Clinic, P.C.
Dubuque, Iowa, 52002, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Sabates Eye Centers Research Division
Leawood, Kansas, 66211, United States
Retina and Vitreous Associates of Kentucky
Lexington, Kentucky, 40509-1802, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Elman Retina Group, P.A.
Baltimore, Maryland, 21237, United States
Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, 21287-9177, United States
Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, 21287-9277, United States
Retina Consultants of Delmarva, P.A.
Salisbury, Maryland, 21804, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
Detroit, Michigan, 48202, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49525, United States
Retina Center, PA
Minneapolis, Minnesota, 55404, United States
Barnes Retina Institute
St Louis, Missouri, 63110, United States
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648, United States
The New York Eye and Ear Infirmary/Faculty Eye Practice
New York, New York, 10003, United States
Mount Sinai School of Medicine, Dept. of Ophthalmology
New York, New York, 10029, United States
Retina Consultants of Western New York
Orchard Park, New York, 14127, United States
Eye Care for the Adirondacks
Plattsburgh, New York, 12901, United States
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York, 13224, United States
University of North Carolina, Dept of Ophthalmology
Chapel Hill, North Carolina, 27599-7040, United States
Charlotte Eye Ear Nose and Throat Assoc, PA
Charlotte, North Carolina, 28210, United States
Piedmont Retina Specialists, PA
Greensboro, North Carolina, 27401, United States
Mid-America Retina Consultants, P.A.
Kansas City, North Carolina, 64111, United States
Wake Forest University Eye Center
Winston-Salem, North Carolina, 27157, United States
Retina Associates of Cleveland, Inc.
Beachwood, Ohio, 44122, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
OSU Eye Physicians and Surgeons, LLC.
Columbus, Ohio, 43212, United States
Retina Northwest, PC
Portland, Oregon, 97210, United States
Family Eye Group
Lancaster, Pennsylvania, 17601-2644, United States
University of Pennsylvania Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
Carolina Retina Center
Columbia, South Carolina, 29223, United States
Southeastern Retina Associates, PC
Kingsport, Tennessee, 37660, United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, 37909, United States
West Texas Retina Consultants P.A.
Abilene, Texas, 79605, United States
Retina Research Center
Austin, Texas, 78705, United States
Retina and Vitreous of Texas
Houston, Texas, 77025, United States
Baylor Eye Physicians and Surgeons
Houston, Texas, 77030, United States
Texas Retina Associates
Lubbock, Texas, 79424, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Retinal Consultants of San Antonio
San Antonio, Texas, 78240, United States
Virginia Retina Center
Leesburg, Virginia, 20176, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Medical College of Wiconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Bhavsar AR, Torres K, Glassman AR, Jampol LM, Kinyoun JL; Diabetic Retinopathy Clinical Research Network. Evaluation of results 1 year following short-term use of ranibizumab for vitreous hemorrhage due to proliferative diabetic retinopathy. JAMA Ophthalmol. 2014 Jul;132(7):889-90. doi: 10.1001/jamaophthalmol.2014.287. No abstract available.
PMID: 25010170BACKGROUNDDiabetic Retinopathy Clinical Research Network*. Randomized clinical trial evaluating intravitreal ranibizumab or saline for vitreous hemorrhage from proliferative diabetic retinopathy. JAMA Ophthalmol. 2013 Mar;131(3):283-93. doi: 10.1001/jamaophthalmol.2013.2015.
PMID: 23370902RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam R. Glassman
- Organization
- Diabetic Retinopathy Clinical Research Network
Study Officials
- STUDY DIRECTOR
Adam R. Glassman, MS
Jaeb Center for Health Research
- STUDY CHAIR
Abdhish Bhavsar, MD
Retina Center, PA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2009
First Posted
October 16, 2009
Study Start
June 1, 2010
Primary Completion
February 1, 2012
Study Completion
January 1, 2013
Last Updated
August 26, 2016
Results First Posted
May 16, 2013
Record last verified: 2016-08