Diabetic Macula EdemaPhase 4NCT02131350
Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
A Phase 4 study testing Photocoagulation and Ranibizumab in people with Diabetic Macula Edema, run by Shinshu University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Macula Edema
- What is being tested?
- Photocoagulation and Ranibizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2014to Mar 2018
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable medication for the management of diabetes within 3 months
- visual impairment due to focal or diffuse diabetic macula edema
- decreased vision due to diabetic macula edema and not other causes
Who cannot join
- concomitant conditions in the study eye that could prevent the improvement in VA on the study
- active intraocular inflammation or infection in either eye
- uncontrolled glaucoma in either eye
- treatment with antiangiogenic drugs in the study eye within 3 months
- history of stroke and uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department ou Ophthalmology Shinshu University School of Medicine
Matsumoto, Nagano, 3908621
About this study
The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.
- Conditions
- Diabetic Macula Edema
- Being tested
- Photocoagulation, Ranibizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotocoagulationProcedure or surgery
Photocoagulation include focal/grid laser and/or panretinal photocoagulation
RanibizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab with Photocoagulation | Experimental | Not described Receives: Procedure: Photocoagulation; Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.
Measured: every month, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macula EdemaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shinshu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takao Hirano, Shinshu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131350
- Sponsor's protocol ID
- 2617
- Status last verified
- Sep 2018
- First submitted
- 22 Apr 2014
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
- ClinicalTrials.gov ID
- NCT02131350
- Acronym / sponsor ID
- 2617
- Conditions
- Diabetic Macula Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 6 May 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.
The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab with Photocoagulation | Experimental | Procedure: Photocoagulation, Drug: Ranibizumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stable medication for the management of diabetes within 3 months
- visual impairment due to focal or diffuse diabetic macula edema
- decreased vision due to diabetic macula edema and not other causes
Key exclusion criteria (5 listed)
- concomitant conditions in the study eye that could prevent the improvement in VA on the study
- active intraocular inflammation or infection in either eye
- uncontrolled glaucoma in either eye
- treatment with antiangiogenic drugs in the study eye within 3 months
- history of stroke and uncontrolled hypertension
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 |
|---|---|---|
| PhotocoagulationPhotocoagulation include focal/grid laser and/or panretinal photocoagulation | Procedure or surgery | Ranibizumab with Photocoagulation |
| Ranibizumab | Drug | Ranibizumab with Photocoagulation |
Primary outcome
best corrected visual acuity
Time frame: every month, up to 36 months
Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.
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 7 Sep 2018.
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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.
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 Phase 4 study testing Photocoagulation and Ranibizumab in people with Diabetic Macula Edema, run by Shinshu 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 3 inclusion and 5 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 7 Sep 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
best corrected visual acuity (time frame: every month, up to 36 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 7 Sep 2018.