Anti-VEGF vs. Prompt Vitrectomy for VH From PDR

Last updated: March 24, 2021
Sponsor: Jaeb Center for Health Research
Overall Status: Completed

Phase

2/3

Condition

Diabetic Retinopathy

Diabetic Vitreous Hemorrhage

Hemorrhage

Treatment

N/A

Clinical Study ID

NCT02858076
DRCR.net Protocol AB
EY23207
EY18817
EY14231
  • Ages > 18
  • All Genders

Study Summary

Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including greater visual acuity improvement and reduced rates of recurrent VH as compared with saline injection. It is possible that a study with a longer duration of follow-up with structured anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the other hand, advances in surgical techniques leading to faster operative times, quicker patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive alternative since it results in the immediate ability to clear hemorrhage and to perform PRP if desired, often as part of one procedure. This proposed study will evaluate the safety and efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and intravitreous aflibercept injections.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.
  2. 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.
  1. 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.
  1. 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).
  2. Visual acuity letter score ≤78 (approximate Snellen equivalent 20/32) and atleast light perception.
  3. 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:
  1. History of chronic renal failure requiring dialysis (including placement offistula if performed in preparation for dialysis) or kidney transplant.
  2. 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).
  3. 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.
  4. A condition that, in the opinion of the investigator, would preclude participantundergoing elective vitrectomy surgery if indicated during the study.
  5. 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.
  6. Known allergy to any component of the study drug or any drug used in theinjection prep (including povidone iodine).
  7. Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
  8. If blood pressure is brought below 180/110 by anti-hypertensive treatment,potential participant can become eligible.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. Evidence of neovascular glaucoma (iris or angle neovascularization is not anexclusion).
  15. Known diabetic macular edema (DME), defined as either
  16. Optical coherence tomography central subfield thickness (microns):
  17. Zeiss Cirrus: ≥290 in women; ≥305 in men
  18. Heidelberg Spectralis: ≥305 in women; ≥320 in men OR
  19. Diabetic macular edema on clinical exam that the investigator believes currentlyrequires treatment.
  20. History of intravitreous anti-vascular endothelial growth factor treatment within 2 months prior to current vitreous hemorrhage onset or after onset.
  21. History of intraocular corticosteroid treatment within 4 months prior to currentvitreous hemorrhage onset or after onset.
  22. 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.
  23. History of vitrectomy.
  24. History of YAG capsulotomy performed within 2 months prior to randomization.
  25. Aphakia.
  26. Uncontrolled glaucoma (in investigator's judgment).
  27. Exam evidence of severe external ocular infection, including conjunctivitis,chalazion, or substantial blepharitis.

Study Design

Total Participants: 205
Study Start date:
November 01, 2016
Estimated Completion Date:
January 31, 2020

Study Description

A participant could have only one eye enrolled in the study.

Connect with a study center

  • UBC/VCHA Eye Care Centre

    Vancouver, British Columbia V5Z 3N9
    Canada

    Site Not Available

  • University Health Network - Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Retinal Diagnostic Center

    Campbell, California 95008
    United States

    Site Not Available

  • Macula & Retina Institute

    Glendale, California 91203
    United States

    Site Not Available

  • Atlantis Eye Care

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Loma Linda University Health Care, Department of Ophthalmology

    Loma Linda, California 92354
    United States

    Site Not Available

  • Shashi D Ganti, MD PC

    Porterville, California 93257
    United States

    Site Not Available

  • Florida Retina Consultants

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Retina Associates of Sarasota

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Retina Associates of Florida, P.A.

    Tampa, Florida 33609
    United States

    Site Not Available

  • Emory Eye Center

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Southeast Retina Center, P.C.

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Marietta Eye Clinic

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Thomas Eye Group

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Gailey Eye Clinic

    Bloomington, Illinois 61704
    United States

    Site Not Available

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Raj K. Maturi, MD, PC

    Indianapolis, Indiana 42690
    United States

    Site Not Available

  • John-Kenyon American Eye Institute

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Retina Associates, P.A.

    Shawnee, Kansas 66204
    United States

    Site Not Available

  • Retina Associates, P.A.

    Shawnee Mission, Kansas 66204
    United States

    Site Not Available

  • Paducah Retinal Center

    Paducah, Kentucky 42001
    United States

    Site Not Available

  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana 71291
    United States

    Site Not Available

  • Elman Retina Group, P.A.

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Wilmer Eye Institute at Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts 01432
    United States

    Site Not Available

  • Joslin Diabetes Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Kellogg Eye Center, University of Michigan

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Retina Specialists of Michigan

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Retina Center, PA

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Mayo Clinic Department of Ophthalmology

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mid-America Retina Consultants, P.A.

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • The Retina Institute

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • MaculaCare

    New York, New York 10021
    United States

    Site Not Available

  • The New York Eye and Ear Infirmary/Faculty Eye Practice

    New York, New York 10003
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Site Not Available

  • Retina-Vitreous Surgeons of Central New York, PC

    Syracuse, New York 13224
    United States

    Site Not Available

  • Kittner Eye Center

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Charlotte Eye, Ear, Nose and Throat Assoc., PA

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Retina Associates of Cleveland, Inc.

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Retina Vitreous Center

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oregon Retina, LLP

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Casey Eye Institute

    Portland, Oregon 97239
    United States

    Site Not Available

  • Retina Northwest, PC

    Portland, Oregon 97221
    United States

    Site Not Available

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania 15146
    United States

    Site Not Available

  • Palmetto Retina Center

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Southeastern Retina Associates

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Southwest Retina Specialists

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Retina Research Center

    Austin, Texas 78705
    United States

    Site Not Available

  • Baylor Eye Physicians and Surgeons

    Houston, Texas 77030
    United States

    Site Not Available

  • Retina and Vitreous of Texas

    Houston, Texas 77025
    United States

    Site Not Available

  • Texas Retina Associates

    Lubbock, Texas 79424
    United States

    Site Not Available

  • Valley Retina Institute

    McAllen, Texas 78503
    United States

    Site Not Available

  • Medical Center Ophthalmology Associates

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retinal Consultants of San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Spokane Eye Clinic

    Spokane, Washington 99204
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.