Bevacizumab treatment for diabetic eye surgery patients

Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy

This study is testing if giving a medication called bevacizumab right after eye surgery can help people with diabetic eye disease see better and avoid complications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Christian Ophthalmic Surgery Expedition Network (other)
• Drugs / interventions: bevacizumab
• Locations: 1 site (Querétaro City, Querétaro)
• Trial ID: NCT06899529 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of administering bevacizumab immediately after vitrectomy in patients with proliferative diabetic retinopathy. Participants will be randomly assigned to receive either the treatment or a placebo at the end of their surgery. The study aims to evaluate the potential benefits of this intervention in improving visual outcomes and reducing complications associated with the condition. Patients will be monitored for six months following the procedure to assess the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with type I or II diabetes and active proliferative diabetic retinopathy requiring vitrectomy.

Not a fit: Patients who do not have proliferative diabetic retinopathy or those with other eye conditions unrelated to diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision and reduce complications for patients with proliferative diabetic retinopathy undergoing surgery.

How similar studies have performed: Previous studies have shown promising results with bevacizumab in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

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.

   \-

Where this trial is running

Querétaro City, Querétaro

• Sky Vision — Querétaro City, Querétaro, Mexico (RECRUITING)

Study contacts

• Principal investigator: Isaac Aleman, MD — Christian Ophthalmic Surgery Expedition Network
• Study coordinator: Ryan Rush, MD

Conditions: Proliferative Diabetic Retinopathy - High Risk, proliferative diabetic retinopathy, bevacizumab, vitreous hemorrhage