MedDataX Logo

Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

NCT ID: NCT04191954

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-02

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinopathy of Prematurity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fasudil eye drops (concentration 0.5 percent)

twice daily

Group Type ACTIVE_COMPARATOR

Fasudil eye drops (concentration 0.5 percent)

Intervention Type DRUG

receive Fasudil eye drops (concentration 0.5 percent) twice daily

receive artificial tears drop with the same frequency

Group Type PLACEBO_COMPARATOR

receive artificial tears drop

Intervention Type DRUG

receive artificial tears drop with the same frequency

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fasudil eye drops (concentration 0.5 percent)

receive Fasudil eye drops (concentration 0.5 percent) twice daily

Intervention Type DRUG

receive artificial tears drop

receive artificial tears drop with the same frequency

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

45 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zahra Rabbani Khah

Head of ophthalmic research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ophthalmic Research Center

Tehran, , Iran

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iran

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alireza Ramezani, MD

Role: CONTACT

Phone: 009822591616

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ali reza Ramezani, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9800

Identifier Type: -

Identifier Source: org_study_id