Retinopathy of PrematurityPhase 2/3NCT04191954
Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)
A Phase 2/3 study testing Fasudil eye drops (concentration 0.5 percent) and receive artificial tears drop in people with Retinopathy of Prematurity, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 weeksHealthy volunteers can take part
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Fasudil eye drops (concentration 0.5 percent) and receive artificial tears drop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteIran
- Study dates
- 2 Jun 2019to Sep 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2
Who cannot join
- Serious systemic problems
- Other ocular problems Except ROP
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Ali reza Ramezani, MD, 009822591616, labbafi@hotmail.com
About this study
Official title: 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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Fasudil eye drops (concentration 0.5 percent), receive artificial tears drop
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasudil eye drops (concentration 0.5 percent)Drug
receive Fasudil eye drops (concentration 0.5 percent) twice daily
receive artificial tears dropDrug
receive artificial tears drop with the same frequency
| Study group | Role | What they receive |
|---|---|---|
| Fasudil eye drops (concentration 0.5 percent) | Active comparator | twice daily Receives: Drug: Fasudil eye drops (concentration 0.5 percent) |
| receive artificial tears drop with the same frequency | Placebo comparator | Not described Receives: Drug: receive artificial tears drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation of normal retinal vascularization and disease progression inhibition
Fundoscopy and examiner judgment which will be documented by retinal camera
Measured: 3 months
Secondary outcomes (1)
Any adverse event
Neonatologist and ophthalmologist examination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start2 Jun 2019
- Primary completion1 Nov 2019
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191954
- Sponsor's protocol ID
- 9800
- Status last verified
- Nov 2019
- First submitted
- 29 Nov 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasudil Eye Drop in Retinopathy Of Prematurity, Retinal Vascularization Induction and Disease Progression Inhibition, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04191954
- Acronym / sponsor ID
- 9800
- Conditions
- Retinopathy of Prematurity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 2 Jun 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- Sep 2020 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasudil eye drops (concentration 0.5 percent) | Active comparator | Drug: Fasudil eye drops (concentration 0.5 percent)twice daily |
| receive artificial tears drop with the same frequency | Placebo comparator | Drug: receive artificial tears drop |
Who may qualify
- Ages
- Up to 45 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2
Key exclusion criteria (2 listed)
- Serious systemic problems
- Other ocular problems Except ROP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasudil eye drops (concentration 0.5 percent)receive Fasudil eye drops (concentration 0.5 percent) twice daily | Drug | Fasudil eye drops (concentration 0.5 percent) |
| receive artificial tears dropreceive artificial tears drop with the same frequency | Drug | receive artificial tears drop with the same frequency |
Primary outcome
Stimulation of normal retinal vascularization and disease progression inhibition
Time frame: 3 months
Fundoscopy and examiner judgment which will be documented by retinal camera
1 secondary outcome
Any adverse event
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fasudil eye drops (concentration 0.5 percent) and receive artificial tears drop in people with Retinopathy of Prematurity, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alireza Ramezani, MD (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulation of normal retinal vascularization and disease progression inhibition (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.