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Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

NCT04191954 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2019-12-10

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity

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

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
45 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-02
Primary Completion
2019-11-01
Completion
2020-09-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04191954 on ClinicalTrials.gov