Proliferative Diabetic Retinopathy - High Risk
Conditions
Keywords
proliferative diabetic retinopathy, bevacizumab, vitreous hemorrhage
Brief summary
Patients undergoing surgery for complications related to diabetes will be recruited.
Detailed description
Proliferative Diabetic Retinopathy patients undergoing pars plana vitrectomy will be randomized whether or not to receive intravitreal bevacizumab at the conclusion of the operation.
Interventions
PROCEDUREBevacizumab
Bevacizumab will be given immediately after surgery in the Treatment Group
Sponsors
Christian Ophthalmic Surgery Expedition Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and the specialist recording outcomes will be masked.
Intervention model description
Randomized Prospective Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject age is \> 18 2. Subject consents to study participation and is capable of 6 months of follow-up. 3. The subject has type I or II Diabetes Mellitus with active PDR in the study eye. 4. Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to Hand Motions in the study eye. 5. The subject is determined to need a PPV because of reduced BCSVA principally from a non-clearing vitreous hemorrhage, TRD, fibrous proliferation, or a combination of the three. When non-clearing vitreous hemorrhage is the principal reason for PPV, the hemorrhage must have been present by subjective history for at least 3 months. When TRD is the principal reason for PPV, the TRD must be threatening (within one disc diameter) or involving the fovea. When fibrovascular proliferation is the principal reason for PPV, it must be extensive (\>3 clock hours) and threatening (within one disc diameter) or involving the fovea. 6. Only one eye per patient is eligible for the study.
Exclusion criteria
1. 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. 2. 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. 3. Subject has had a previous vitrectomy (anterior or PPV) in the study eye. 4. Subject has uncontrolled neovascular glaucoma (intraocular pressure \> 30 mmHg despite medical/surgical treatment) in the study eye. 5. Subject has uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | 6 months | Postoperative vitreous hemorrhage rate |
Countries
Mexico
Contacts
Primary ContactRyan Rush, MD
Backup ContactChristi Rush
Outcome results
None listed