Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

Overview

Eligible eyes are randomly assigned into two groups. Group A receive Fasudil eye drops (concentration 0.5 percent) twice daily. Group B, receive artificial tears drop with the same frequency. Retinal specialists who are expert in Retinopathy Of Prematurity field will perform fundus examination regularly. The examiners are blind. The progression of normal retinal vascularization and need to treatment will be documented and compared between the two study groups. The topical eye drops are used until the retinal vascularization are complete (45 week after LMP) or the patient needs to be treated.

Full Title of Study: “Fasudil Eye Drop in Retinopathy Of Prematurity, Retinal Vascularization Induction and Disease Progression Inhibition, a Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: November 1, 2019

Interventions

  • Drug: Fasudil eye drops (concentration 0.5 percent)
    • receive Fasudil eye drops (concentration 0.5 percent) twice daily
  • Drug: receive artificial tears drop
    • receive artificial tears drop with the same frequency

Arms, Groups and Cohorts

  • Active Comparator: Fasudil eye drops (concentration 0.5 percent)
    • twice daily
  • Placebo Comparator: receive artificial tears drop with the same frequency

Clinical Trial Outcome Measures

Primary Measures

  • Stimulation of normal retinal vascularization and disease progression inhibition
    • Time Frame: 3 months
    • Fundoscopy and examiner judgment which will be documented by retinal camera

Secondary Measures

  • Any adverse event
    • Time Frame: 3 months
    • Neonatologist and ophthalmologist examination

Participating in This Clinical Trial

Inclusion Criteria

  • Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2 Exclusion Criteria:

  • Serious systemic problems – Other ocular problems Except ROP

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 45 Weeks

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shahid Beheshti University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zahra Rabbani Khah, Head of ophthalmic research center – Shahid Beheshti University of Medical Sciences
  • Overall Contact(s)
    • Alireza Ramezani, MD, 009822591616, labbafi@hotmail.com

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