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Patients undergoing surgery for complications related to diabetes will be recruited.
Proliferative Diabetic Retinopathy patients undergoing pars plana vitrectomy will be randomized whether or not to receive intravitreal bevacizumab at the conclusion of the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | Receives postoperative bevacizumab |
|
| Control Group | No Intervention | Does NOT receive postoperative bevacizumab |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Procedure | Bevacizumab will be given immediately after surgery in the Treatment Group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Postoperative vitreous hemorrhage rate | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
Subject has a significant corneal opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Rush, MD | Contact | 18066740200 | chosenmedical@gmail.com | |
| Christi Rush | Contact | 8066740200 |
| Name | Affiliation | Role |
|---|---|---|
| Isaac Aleman, MD | Christian Ophthalmic Surgery Expedition Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sky Vision | Recruiting | Querétaro City | Querétaro | 76165 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30705040 | Result | Aleman I, Castillo Velazquez J, Rush SW, Rush RB. Ziv-aflibercept versus bevacizumab administration prior to diabetic vitrectomy: a randomised and controlled trial. Br J Ophthalmol. 2019 Dec;103(12):1740-1746. doi: 10.1136/bjophthalmol-2018-313313. Epub 2019 Jan 31. | |
| 31047488 | Result | Castillo Velazquez J, Aleman I, Rush SW, Rush RB. Bevacizumab before Diabetic Vitrectomy: A Clinical Trial Assessing 3 Dosing Amounts. Ophthalmol Retina. 2018 Oct;2(10):1010-1020. doi: 10.1016/j.oret.2018.04.014. Epub 2018 Oct 3. |
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| ID | Term |
|---|---|
| D014823 | Vitreous Hemorrhage |
| ID | Term |
|---|---|
| D005130 | Eye Hemorrhage |
| D005128 | Eye Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Randomized Prospective Clinical Trial
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Patients and the specialist recording outcomes will be masked.
| 28860046 | Result | Castillo J, Aleman I, Rush SW, Rush RB. Preoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: A Randomized and Controlled Trial Comparing Interval Variation. Am J Ophthalmol. 2017 Nov;183:1-10. doi: 10.1016/j.ajo.2017.08.013. Epub 2017 Aug 30. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |