NCT06899529Recruiting
Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Patients undergoing surgery for complications related to diabetes will be recruited.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 21 Mar 2025
- Start date
- 20 Mar 2025
- Primary completion date
- 20 Mar 2027
- Lead sponsor
- Christian Ophthalmic Surgery Expedition Network
- Diseases
- Diabetic eye disease
- NCT number
- NCT06899529
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 20 Mar 2025 to the primary completion date, 20 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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 uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
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Other
- 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.
Who the study is looking for
- Subject age is \> 18
- Subject consents to study participation and is capable of 6 months of follow-up.
- The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
- Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to Hand Motions in the study eye.
- 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.
- Only one eye per patient is eligible for the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sky Vision Coordinator of this site? Confirm its status | Querétaro City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.