Submacular HemorrhageNCT02120066
Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm
A study testing Vitrectomy for submacular hemorrhage and subretinal injection of tissue-plasminogen activator in people with Submacular Hemorrhage and Ruptured Retinal Arterial Macro Aneurysms, run by Kyorin University at 1 site in Japan.
Trial summary
Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Submacular Hemorrhage, Ruptured Retinal Arterial Macro Aneurysms
- What is being tested?
- Vitrectomy for submacular hemorrhage and subretinal injection of tissue-plasminogen activator
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2011to Apr 2014
- Phase
- Interventional
- 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with sub macular hemorrhage associated with ruptured retinal arterial macro aneurysms
Who cannot join
- The eyes with preretinal or intraretinal hemorrhage at the fovea
- The patients with follow-up less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.
- Being tested
- Vitrectomy for submacular hemorrhage, subretinal injection of tissue-plasminogen activator
- Keywords
- Submacular hemorrhage, Vitrectomy, tissue- plasminogen activator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy for submacular hemorrhageProcedure or surgery
subretinal injection of tissue-plasminogen activatorDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitrectomy | Other | Not described Receives: Procedure: Vitrectomy for submacular hemorrhage; Drug: subretinal injection of tissue-plasminogen activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement of sub macular hemorrhage
Anatomical recovery detected funduscopy and optical coherence tomography
Measured: one year
Secondary outcomes (1)
Visual acuity
Visual recovery after surgery
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submacular HemorrhageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Inoue, Kyorin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120066
- Sponsor's protocol ID
- Kyorineye015
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm
- ClinicalTrials.gov ID
- NCT02120066
- Acronym / sponsor ID
- Kyorineye015
- Keywords
- Submacular hemorrhage, Vitrectomy, tissue- plasminogen activator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Apr 2014 (estimated)
- 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.
Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitrectomy | Other | Procedure: Vitrectomy for submacular hemorrhage, Drug: subretinal injection of tissue-plasminogen activator |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients with sub macular hemorrhage associated with ruptured retinal arterial macro aneurysms
Key exclusion criteria (2 listed)
- The eyes with preretinal or intraretinal hemorrhage at the fovea
- The patients with follow-up less than 3 months
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 |
|---|---|---|
| Vitrectomy for submacular hemorrhage | Procedure or surgery | Vitrectomy |
| subretinal injection of tissue-plasminogen activator | Drug | Vitrectomy |
Primary outcome
Displacement of sub macular hemorrhage
Time frame: one year
Anatomical recovery detected funduscopy and optical coherence tomography
1 secondary outcome
Visual acuity
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
- Related InfoLink provided by the sponsor.
Related trials for Submacular Hemorrhage
RecruitingPhase 3
Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
Eye Diseases, Macular Degeneration, Wet
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy for submacular hemorrhage and subretinal injection of tissue-plasminogen activator in people with Submacular Hemorrhage and Ruptured Retinal Arterial Macro Aneurysms, run by Kyorin University at 1 site in Japan.
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: finished, as of the sponsor's last update on 22 Apr 2014. 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 Japan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement of sub macular hemorrhage (time frame: one year). 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 Apr 2014.