- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04191954
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
Status
Unknown
Conditions
Intervention / Treatment
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
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- Ophthalmic Research Center
-
-
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
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Infant, Newborn, Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Infant, Premature, Diseases
- Retinal Diseases
- Premature Birth
- Retinopathy of Prematurity
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Membrane Transport Modulators
- Protein Kinase Inhibitors
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Lubricant Eye Drops
- Fasudil
Other Study ID Numbers
- 9800
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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