NCT05107921

Brief Summary

This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

October 23, 2021

Last Update Submit

November 20, 2023

Conditions

Familial Exudative Vitreoretinopathies

Outcome Measures

Primary Outcomes (1)

  • Macular edema response rate

    Presence of macular edema

    4 weeks after the diode laser photocoagulation

Secondary Outcomes (1)

  • Conjunctival injection response rate

    4 weeks after the diode laser photocoagulation

Study Arms (1)

Bromfenac sodium hydrate eye drops

EXPERIMENTAL

The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days.

Drug: Bromfenac Sodium

Interventions

Bromfenac SodiumDRUG

The study participants will receive bromfenac sodium hydrate eyedrops twice daily for 14 days.

Also known as: Bronuck
Bromfenac sodium hydrate eye drops

Eligibility Criteria

Age1 Month - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newly diagnosed patients with familial exudative vitreoretinopathy
  • Needing diode laser photocoagulation
  • Consent to the study

You may not qualify if:

  • History of corneal diseases
  • History of hypersensitivity to bromfenac sodium
  • History of hypersensitivity to non-steroidal anti-inflammatory drugs
  • Progressive ocular infection
  • Liver diseases
  • Hypersensitivity to sulfur dioxide
  • Receiving anti-coagulation drugs
  • History of coagulopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Familial Exudative Vitreoretinopathies

Interventions

bromfenac

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesEye Diseases, HereditaryRetinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Jeong Hun Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong Hun Kim, MD, PhD

CONTACT

82-2-2072-3446steph25@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2021

First Posted

November 4, 2021

Study Start

November 1, 2021

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)