Incidence of hypoxia during intravitreal ranibizumab injections for retinopathy of prematurity under topical anesthesia
Official title: Hyopxia During Anti-VEGF Injection
Run by Minia University · NCT07701759 · Data updated 2026-11-12
This study looks at how often and how severely babies with retinopathy of prematurity experience low oxygen levels during bedside eye injections with topical anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 74 (estimated) |
| Sponsor | Minia University Academic / other |
| Drugs / interventions | ranibizumab, Bevacizumab |
| Locations | 1 site (Buraidah) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | July 15, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07701759 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Premature infants with treatment-requiring ROP who received intravitreal ranibizumab and had complete procedural monitoring and available follow-up data.
✕Probably not a fit
Infants without complete procedural or follow-up data or those with major cardiorespiratory anomalies not related to the eye procedure may not benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This retrospective multicenter observational study examined premature infants treated with intravitreal ranibizumab for treatment-requiring ROP between July 2020 and June 2026 at Qassim University Medical City. During each bedside procedure, continuous pulse oximetry was recorded to classify hypoxia as mild, moderate, or severe. The analysis included demographic, maternal, perinatal, ophthalmic, and treatment-related variables to describe incidence and severity and to identify potential risk factors. The goal is to address an evidence gap regarding intraprocedural hypoxia in this setting across multiple hospitals in the Al Qassim region of Saudi Arabia.
Why it matters
Potential benefit: If successful, the study could clarify intraprocedural oxygen risk and guide monitoring practices to improve safety during intravitreal injections in premature infants.
How similar studies have gone: Previous research on intraprocedural hypoxia in this exact setting is sparse, making this study a novel contribution with potential to inform practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * Premature infants with treatment-requiring ROP. * Treatment with intravitreal ranibizumab. * Complete procedural monitoring records, including continuous pulse oximetry. * Availability of follow-up data after treatment. Exclusion criteria Infants were excluded if they had: * Incomplete procedural or follow-up data. * Major congenital anomalies affecting cardiorespiratory function. * Bronchopulmonary dysplasia. * Intraventricular hemorrhage. * Patent ductus arteriosus. * Respiratory distress syndrome requiring surfactant therapy.
Where it's running
-
Qumc
Buraidah, Saudi Arabia Recruiting
Study contacts
- Study coordinator: Shaaban A Elwan, professor of ophthalmology
- Email: shaabanhamid29@gmail.com
- Phone: 00966509507738
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.