Bevacizumab treatment for diabetic eye surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

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Where it's running

• Sky Vision
  Querétaro City, Querétaro, Mexico Recruiting

Study contacts

• Principal investigator: Isaac Aleman, MD — Christian Ophthalmic Surgery Expedition Network
• Study coordinator: Ryan Rush, MD
• Email: chosenmedical@gmail.com
• Phone: 18066740200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.