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Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

Primary Purpose

Retinopathy of Prematurity

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Fasudil eye drops (concentration 0.5 percent)
receive artificial tears drop
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity

Eligibility Criteria

undefined - 45 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fasudil eye drops (concentration 0.5 percent)

receive artificial tears drop with the same frequency

Arm Description

twice daily

Outcomes

Primary Outcome Measures

Stimulation of normal retinal vascularization and disease progression inhibition
Fundoscopy and examiner judgment which will be documented by retinal camera

Secondary Outcome Measures

Any adverse event
Neonatologist and ophthalmologist examination

Full Information

First Posted
November 29, 2019
Last Updated
December 5, 2019
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04191954
Brief Title
Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)
Official Title
Fasudil Eye Drop in Retinopathy Of Prematurity, Retinal Vascularization Induction and Disease Progression Inhibition, a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fasudil eye drops (concentration 0.5 percent)
Arm Type
Active Comparator
Arm Description
twice daily
Arm Title
receive artificial tears drop with the same frequency
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fasudil eye drops (concentration 0.5 percent)
Intervention Description
receive Fasudil eye drops (concentration 0.5 percent) twice daily
Intervention Type
Drug
Intervention Name(s)
receive artificial tears drop
Intervention Description
receive artificial tears drop with the same frequency
Primary Outcome Measure Information:
Title
Stimulation of normal retinal vascularization and disease progression inhibition
Description
Fundoscopy and examiner judgment which will be documented by retinal camera
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Any adverse event
Description
Neonatologist and ophthalmologist examination
Time Frame
3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
45 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alireza Ramezani, MD
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali reza Ramezani, MD
Phone
009822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

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Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

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