Phase
Condition
Diabetic Retinopathy
Diabetic Vitreous Hemorrhage
Hemorrhage
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age >= 18 years Participants <18 years old are not being included becauseproliferative diabetic retinopathy is so rare in this age group that the diagnosis maybe questionable.
- Diagnosis of diabetes mellitus (type 1 or type 2) Any one of the following will be considered to be sufficient evidence that diabetes ispresent:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
- Documented diabetes by American Diabetes Association and/or World Health Organizationcriteria 4. Able and willing to provide informed consent. 5. Patient is willing andable to undergo vitrectomy within next 2 weeks and the vitrectomy can be scheduledwithin that time frame.
- Vitreous hemorrhage causing vision impairment, presumed to be from proliferativediabetic retinopathy, for which intervention is deemed necessary.
- Note: Prior panretinal photocoagulation is neither a requirement nor anexclusion.
- Subhyaloid hemorrhage alone does not make an eye eligible; however, presence ofsubhyaloid hemorrhage in addition to the criteria above will not precludeparticipation provided the investigator is comfortable with either treatmentregimen.
- Immediate vitrectomy not required (investigator and participant are willing towait at least 4 months to see if hemorrhage clears sufficiently withanti-vascular endothelial growth factor without having to proceed to vitrectomy).
- Visual acuity letter score ≤78 (approximate Snellen equivalent 20/32) and atleast light perception.
- Investigators should use particular caution when considering enrollment of aneye with visual acuity letter score 69 to 78 (approximate Snellen equivalent 20/32 to 20/40) to ensure that the need for vitrectomy and its potential benefitsoutweigh the potential risks.
Exclusion
Exclusion Criteria:
- A potential participant is not eligible if any of the following exclusion criteria arepresent:
- History of chronic renal failure requiring dialysis (including placement offistula if performed in preparation for dialysis) or kidney transplant.
- A condition that, in the opinion of the investigator, would precludeparticipation in the study (e.g., unstable medical status including bloodpressure, cardiovascular disease, and glycemic control).
- Initiation of intensive insulin treatment (a pump or multiple daily injections)within 4 months prior to randomization or plans to do so in the next 4 months.
- A condition that, in the opinion of the investigator, would preclude participantundergoing elective vitrectomy surgery if indicated during the study.
- Participation in an investigational trial within 30 days of randomization thatinvolved treatment with any drug that has not received regulatory approval forthe indication being studied. • Note: participants cannot receive another investigational drug whileparticipating in the study.
- Known allergy to any component of the study drug or any drug used in theinjection prep (including povidone iodine).
- Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
- If blood pressure is brought below 180/110 by anti-hypertensive treatment,potential participant can become eligible.
- Systemic anti-vascular endothelial growth factor or pro-vascular endothelialgrowth factor treatment within 4 months prior to randomization. • These drugs cannot be used during the study.
- For women of child-bearing potential: pregnant or lactating or intending tobecome pregnant within the next two years. • Women who are potential participants should be questioned about the potentialfor pregnancy. Investigator judgment is used to determine when a pregnancy testis needed.
- Potential participant is expecting to move out of the area of the clinical centerto an area not covered by another clinical center during the two years.
- Evidence of traction detachment involving or threatening the macula. • If the density of the hemorrhage precludes a visual assessment on clinical examto confirm eligibility, then it is recommended that assessment be performed withultrasound as standard care.
- Evidence of rhegmatogenous retinal detachment. • If the density of the hemorrhage precludes a visual assessment on clinical examto confirm eligibility, then it is recommended that assessment be performed withultrasound as standard care.
- Evidence of neovascular glaucoma (iris or angle neovascularization is not anexclusion).
- Known diabetic macular edema (DME), defined as either
- Optical coherence tomography central subfield thickness (microns):
- Zeiss Cirrus: ≥290 in women; ≥305 in men
- Heidelberg Spectralis: ≥305 in women; ≥320 in men OR
- Diabetic macular edema on clinical exam that the investigator believes currentlyrequires treatment.
- History of intravitreous anti-vascular endothelial growth factor treatment within 2 months prior to current vitreous hemorrhage onset or after onset.
- History of intraocular corticosteroid treatment within 4 months prior to currentvitreous hemorrhage onset or after onset.
- History of major ocular surgery (including cataract extraction, scleral buckle,any intraocular surgery, etc.) within prior 4 months or major ocular surgeryother than vitrectomy anticipated within the next 6 months followingrandomization.
- History of vitrectomy.
- History of YAG 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.
Study Design
Study Description
Connect with a study center
UBC/VCHA Eye Care Centre
Vancouver, British Columbia V5Z 3N9
CanadaSite Not Available
University Health Network - Toronto Western Hospital
Toronto, Ontario M5T 2S8
CanadaSite Not Available
Retinal Diagnostic Center
Campbell, California 95008
United StatesSite Not Available
Macula & Retina Institute
Glendale, California 91203
United StatesSite Not Available
Atlantis Eye Care
Huntington Beach, California 92647
United StatesSite Not Available
Loma Linda University Health Care, Department of Ophthalmology
Loma Linda, California 92354
United StatesSite Not Available
Shashi D Ganti, MD PC
Porterville, California 93257
United StatesSite Not Available
Florida Retina Consultants
Lakeland, Florida 33805
United StatesSite Not Available
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida 33782
United StatesSite Not Available
Retina Associates of Sarasota
Sarasota, Florida 34233
United StatesSite Not Available
Retina Associates of Florida, P.A.
Tampa, Florida 33609
United StatesSite Not Available
Emory Eye Center
Atlanta, Georgia 30322
United StatesSite Not Available
Southeast Retina Center, P.C.
Augusta, Georgia 30909
United StatesSite Not Available
Marietta Eye Clinic
Marietta, Georgia 30060
United StatesSite Not Available
Thomas Eye Group
Sandy Springs, Georgia 30328
United StatesSite Not Available
Gailey Eye Clinic
Bloomington, Illinois 61704
United StatesSite Not Available
Northwestern Medical Faculty Foundation
Chicago, Illinois 60611
United StatesSite Not Available
University of Illinois at Chicago Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Carle Foundation Hospital
Urbana, Illinois 61801
United StatesSite Not Available
Raj K. Maturi, MD, PC
Indianapolis, Indiana 42690
United StatesSite Not Available
John-Kenyon American Eye Institute
New Albany, Indiana 47150
United StatesSite Not Available
Retina Associates, P.A.
Shawnee, Kansas 66204
United StatesSite Not Available
Retina Associates, P.A.
Shawnee Mission, Kansas 66204
United StatesSite Not Available
Paducah Retinal Center
Paducah, Kentucky 42001
United StatesSite Not Available
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
West Monroe, Louisiana 71291
United StatesSite Not Available
Elman Retina Group, P.A.
Baltimore, Maryland 21237
United StatesSite Not Available
Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland 21287
United StatesSite Not Available
Valley Eye Physicians and Surgeons
Ayer, Massachusetts 01432
United StatesSite Not Available
Joslin Diabetes Center
Boston, Massachusetts 02215
United StatesSite Not Available
Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan 48105
United StatesSite Not Available
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
Detroit, Michigan 48202
United StatesSite Not Available
Retina Specialists of Michigan
Grand Rapids, Michigan 49546
United StatesSite Not Available
Retina Center, PA
Minneapolis, Minnesota 55404
United StatesSite Not Available
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota 55905
United StatesSite Not Available
Mid-America Retina Consultants, P.A.
Kansas City, Missouri 64111
United StatesSite Not Available
The Retina Institute
Saint Louis, Missouri 63128
United StatesSite Not Available
MaculaCare
New York, New York 10021
United StatesSite Not Available
The New York Eye and Ear Infirmary/Faculty Eye Practice
New York, New York 10003
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10021
United StatesSite Not Available
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York 13224
United StatesSite Not Available
Kittner Eye Center
Chapel Hill, North Carolina 27517
United StatesSite Not Available
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, North Carolina 28210
United StatesSite Not Available
Retina Associates of Cleveland, Inc.
Beachwood, Ohio 44122
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Retina Vitreous Center
Edmond, Oklahoma 73013
United StatesSite Not Available
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Oregon Retina, LLP
Eugene, Oregon 97401
United StatesSite Not Available
Casey Eye Institute
Portland, Oregon 97239
United StatesSite Not Available
Retina Northwest, PC
Portland, Oregon 97221
United StatesSite Not Available
Retina Vitreous Consultants
Monroeville, Pennsylvania 15146
United StatesSite Not Available
Palmetto Retina Center
West Columbia, South Carolina 29169
United StatesSite Not Available
Southeastern Retina Associates
Chattanooga, Tennessee 37421
United StatesSite Not Available
Southeastern Retina Associates, P.C.
Knoxville, Tennessee 37909
United StatesSite Not Available
Southwest Retina Specialists
Amarillo, Texas 79106
United StatesSite Not Available
Retina Research Center
Austin, Texas 78705
United StatesSite Not Available
Baylor Eye Physicians and Surgeons
Houston, Texas 77030
United StatesSite Not Available
Retina and Vitreous of Texas
Houston, Texas 77025
United StatesSite Not Available
Texas Retina Associates
Lubbock, Texas 79424
United StatesSite Not Available
Valley Retina Institute
McAllen, Texas 78503
United StatesSite Not Available
Medical Center Ophthalmology Associates
San Antonio, Texas 78240
United StatesSite Not Available
Retinal Consultants of San Antonio
San Antonio, Texas 78240
United StatesSite Not Available
Spokane Eye Clinic
Spokane, Washington 99204
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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