Incidence of Hypoxia During Intravitreal Anti-VEGF (Vascular Endothelial Growth Factor) Injections for Retinopathy of Prematurity (ROP) Under Topical Anesthesia

NCT07701759 | Recruiting DMC

• 1 other identifier: QUMC
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To evaluate the incidence and severity of hypoxia and address a genuine evidence gap focusing on intraprocedural hypoxia during bedside intravitreal ranibizumab injection for retinopathy of prematurity (ROP), an area that has been only sparsely investigated in premature infants treated across multiple hospitals in the Al Qassim region of Saudi Arabia Methods: A retrospective multicenter observational study was conducted at Ophthalmology Department, Qassim University Medical City involving premature infants who underwent intravitreal Ranibizumab injection for treatment-requiring ROP between July 2020 and June 2026. Demographic, maternal, perinatal, ophthalmic, and treatment-related data were collected registered and analyzed. Continuous pulse oximetry monitoring was recorded during bedside neonatal intensive care unit (NICU) procedures. Hypoxia was classified as mild (oxygen saturation 85-89%), moderate (80-84%), or severe (\<80%).

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• Hyopxia

  Incidence of hypoxia during intravitreal anti-VEGF

  1 year

Interventions

ranibizumab DRUG

Intra-vitrail injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A retrospective multicenter observational study was conducted at Ophthalmology Department, Qassim University Medical City involving premature infants who underwent intravitreal Ranibizumab injection for treatment-requiring ROP between July 2020 and June 2026. Demographic, maternal, perinatal, ophthalmic, and treatment-related data were collected registered and analyzed.

You may qualify if:

• Premature infants with treatment-requiring ROP.
• Treatment with intravitreal ranibizumab.
• Complete procedural monitoring records, including continuous pulse oximetry.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

QUMC

Buraidah, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Shaaban A Elwan, professor of ophthalmology

CONTACT

00966509507738; shaabanhamid29@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of ophthalmology

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 14, 2026
• Study Start: October 1, 2025
• Primary Completion: July 15, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)