Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment

NCT06166914 | Completed

• 1 other identifier: 9163209
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

EVALUATION OF 5-FLOUROURACIL AND LOW MOLECULAR WEIGHT HEPARIN INTRAOPERATIVE INFUSION IN PREVENTING PROLIFERATIVE VITREORETINOPATHY IN HIGH RISK PEDIATRIC RHEGMATOGENOUS RETINAL DETACHMENT

Conditions

Retinal Detachment; Proliferative Vitreoretinopathy

Keywords

pediatric retinal detachment; proliferative vitreoretinopathy; 5-Fluorouracil; Low molecular weight heparin

Outcome Measures

Primary Outcomes (1)

• Recurrent RD due to PVR

  Clinical retinal detachment with any grade PVR

  12 weeks post operative

Secondary Outcomes (3)

• Post operative PVR

  12 weeks post operative

• Best corrected visual acuity

  12 weeks post operative

• Secondary procedures

  12 weeks post operative

Study Arms (2)

Treatment group

EXPERIMENTAL

Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml) during pars plana vitrectomy and silicone oil injection with scleral buckle in children under 14 years of age with high-risk PRRD

Drug: Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml)

Control group

PLACEBO COMPARATOR

Group B received infusion of normal saline during pars plana vitrectomy and silicone oil injection with scleral buckle in children under 14 years of age with high-risk PRRD

Drug: Placebo

Interventions

Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml) DRUG

After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml).

Treatment group

Placebo DRUG

After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group B received infusion of normal saline.

Control group

Eligibility Criteria

• Age: 0 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children under 14 years of age with RRD undergoing primary repair Preoperative PVR grade B or higher High risk RRD: uveitis; large, giant, or multiple tears; vitreous hemorrhage; preoperative choroidal detachments; aphakia; and large detachments involving greater than two quadrants of the eye

You may not qualify if:

• Children with RRD related to penetrating ocular trauma involving the posterior segment Previous RD repair surgery Uncontrolled glaucoma or other concomitant ocular morbidities Patients with bleeding diathesis, hepatic and renal failure Corneal opacity sufficient to impair surgical view No light perception vision Inability to complete follow-up

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

• Nasr M, Abdelhadi A, Bessa A, Ibrahim TM. Efficacy of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) in high-risk pediatric retinal detachment; randomized clinical trial. BMC Ophthalmol. 2024 Mar 4;24(1):97. doi: 10.1186/s12886-024-03362-4.

  PMID: 38433191 DERIVED

MeSH Terms

Conditions

Retinal Detachment; Vitreoretinopathy, Proliferative

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized clinical trial of patients enrolled sequentially into group A (treatment) and group B (control)

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: October 21, 2021
• Primary Completion: October 21, 2022
• Study Completion: May 21, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

EG (1)