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Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage From Proliferative Diabetic Retinopathy
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.
A participant could have only one eye enrolled in the study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Retinal Diagnostic Center
Campbell, California, United States
Macula & Retina Institute
Glendale, California, United States
Atlantis Eye Care
Huntington Beach, California, United States
Loma Linda University Health Care, Department of Ophthalmology
Loma Linda, California, United States
Shashi D Ganti, MD PC
Porterville, California, United States
Florida Retina Consultants
Lakeland, Florida, United States
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida, United States
Retina Associates of Sarasota
Sarasota, Florida, United States
Retina Associates of Florida, P.A.
Tampa, Florida, United States
Emory Eye Center
Atlanta, Georgia, United States
Start Date
November 1, 2016
Primary Completion Date
January 1, 2020
Completion Date
January 1, 2020
Last Updated
April 20, 2021
205
ACTUAL participants
2-mg Intravitreous Aflibercept Injection
DRUG
Prompt Vitrectomy Plus Panretinal Photocoagulation
PROCEDURE
Lead Sponsor
Jaeb Center for Health Research
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07236645