Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

December 5, 2019 updated by: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Fasudil Eye Drop in Retinopathy Of Prematurity, Retinal Vascularization Induction and Disease Progression Inhibition, a Randomized Clinical Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

184

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 10 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Fasudil eye drops (concentration 0.5 percent)
twice daily
receive Fasudil eye drops (concentration 0.5 percent) twice daily
PLACEBO_COMPARATOR: receive artificial tears drop with the same frequency
receive artificial tears drop with the same frequency

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any adverse event
Time Frame: 3 months
Neonatologist and ophthalmologist examination
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 2, 2019

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

November 29, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

November 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinopathy of Prematurity

Clinical Trials on Fasudil eye drops (concentration 0.5 percent)

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