Familial Exudative VitreoretinopathiesPhase 2NCT05107921
Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy
A Phase 2 study testing Bromfenac Sodium in people with Familial Exudative Vitreoretinopathies, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation. Read more about this study
- Who is it for?
- Ages 1 month to 7 years
- Conditions the study is for
- Familial Exudative Vitreoretinopathies
- What is being tested?
- Bromfenac Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2021to 20 Oct 2024
- Phase
- Phase 2
- 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 1 month to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newly diagnosed patients with familial exudative vitreoretinopathy
- Needing diode laser photocoagulation
- Consent to the study
Who cannot join
- History of corneal diseases
- History of hypersensitivity to bromfenac sodium
- History of hypersensitivity to non-steroidal anti-inflammatory drugs
- Progressive ocular infection
- Liver diseases
- Hypersensitivity to sulfur dioxide
- Receiving anti-coagulation drugs
- History of coagulopathies
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
IRB Support team Center, 82-2-2072-2613, irb@snuh.org
About this study
Official title: Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation
This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.
Read the detailed description
This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.
- Conditions
- Familial Exudative Vitreoretinopathies
- Being tested
- Bromfenac Sodium
- Medical subject headings
- Familial Exudative Vitreoretinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromfenac SodiumDrug
Also called Bronuck
The study participants will receive bromfenac sodium hydrate eyedrops twice daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Bromfenac sodium hydrate eye drops | Experimental | The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days. Receives: Drug: Bromfenac Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular edema response rate
Presence of macular edema
Measured: 4 weeks after the diode laser photocoagulation
Secondary outcomes (1)
Conjunctival injection response rate
Presence of conjunctival injection
Measured: 4 weeks after the diode laser photocoagulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Nov 2021
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Exudative VitreoretinopathiesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Hun Kim, Seoul National University Hospital
- Investigators
- Jeong Hun Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107921
- Sponsor's protocol ID
- H-2107-210-1239
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation
- ClinicalTrials.gov ID
- NCT05107921
- Acronym / sponsor ID
- H-2107-210-1239
- Conditions
- Familial Exudative Vitreoretinopathies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 4 Nov 2021 (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.
This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.
Detailed description
This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bromfenac sodium hydrate eye drops | Experimental | Drug: Bromfenac SodiumThe patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days. |
Who may qualify
- Ages
- 1 month to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newly diagnosed patients with familial exudative vitreoretinopathy
- Needing diode laser photocoagulation
- Consent to the study
Key exclusion criteria (8 listed)
- History of corneal diseases
- History of hypersensitivity to bromfenac sodium
- History of hypersensitivity to non-steroidal anti-inflammatory drugs
- Progressive ocular infection
- Liver diseases
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 |
|---|---|---|
| Bromfenac SodiumAlso: BronuckThe study participants will receive bromfenac sodium hydrate eyedrops twice daily for 14 days. | Drug | Bromfenac sodium hydrate eye drops |
Primary outcome
Macular edema response rate
Time frame: 4 weeks after the diode laser photocoagulation
Presence of macular edema
1 secondary outcome
Conjunctival injection response rate
Time frame: 4 weeks after the diode laser photocoagulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Jeong Hun Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bromfenac Sodium in people with Familial Exudative Vitreoretinopathies, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 8 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 22 Nov 2023. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Jeong Hun Kim, MD, PhD (82-2-2072-3446, steph25@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular edema response rate (time frame: 4 weeks after the diode laser photocoagulation). 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 22 Nov 2023.