Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

Seoul National University

Status and phase: Enrolling; Phase 2

Conditions: Familial Exudative Vitreoretinopathies

Treatments: Drug: Bromfenac Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT05107921

H-2107-210-1239

Details and patient eligibility

About

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.

Full description

This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

Enrollment: 39 estimated patients

Sex: All

Ages: 1 month to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

39 participants in 1 patient group

Bromfenac sodium hydrate eye drops

Experimental group

Description:

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

Treatment:

Drug: Bromfenac Sodium