Diabetic Macular EdemaNCT05472376
Real-Life Study in Diabetic Macular Edema
An observational study of Diabetic Macular Edema, run by Kocaeli University at 10 sites in Turkey (Türkiye).
Trial summary
The goal of this study is to evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in diabetic macular edema (DME) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Retrospective study
- How many people
- 854 participants
- Where
- 10 sitesTurkey (Türkiye)
- Study dates
- 29 Nov 2020to 15 Jun 2022
- Phase
- Observational
- 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 Any age
- Child, Adult, Older adult
Study population: The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018
Who may be able to join
- Diabetic macular edema treated with intravitreal anti-VEGF injection
- Having at least 4 or more annual examination visits
Who cannot join
- Phacoemulsification surgery in the last 1 month
- PRFK / grid / focal / micropulse in the last 4 months
- Previous intraocular surgery (excluding PPV and phacoemulsification)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Turkey (Türkiye)10 sites
Marmara University School of Medicine
Istanbul
Memorial Şişli Hospital
Istanbul
University Health Sciences, Kartal Dr. Lütfi Kırdar Training and Research Hospital
Istanbul
University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital
Istanbul
University of Health Sciences, Haydarpaşa Numune Training and Research Hospital
Istanbul
University of Health Sciences, Ümraniye Training and Research Hospital
Istanbul
University of Health Sciences, Şişli Etfal Training and Research Hospital
Istanbul
Kocaeli University School of Medicine
Kocaeli, None Selected, 41001
University of Health Sciences, Derince Training and Research Hospital
Kocaeli
Sakarya University School of Medicine
Sakarya
About this study
Official title: Real-World Outcomes of Anti-VEGF Treatment for Diabetic Macular Edema in Turkey: A Multicenter Retrospective Study, MARMASIA Study Group
The goal of this study is to evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in diabetic macular edema (DME) patients.
Read the detailed description
The study included patients who were being observed in the retina departments of 8 tertiary hospitals in the Northern Marmara Region of Turkey (Istanbul's Asian Side, Kocaeli, and Sakarya). The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018 were reviewed.
- Conditions
- Diabetic Macular Edema
- Being tested
- Retrospective study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective studyOther
Retrospective study
| Study group | Role | What they receive |
|---|---|---|
| 3-month follow-up | Not described Receives: Other: Retrospective study | |
| 6-month follow-up | Not described Receives: Other: Retrospective study | |
| 12-month follow-up | Not described Receives: Other: Retrospective study | |
| 24-month follow-up | Not described Receives: Other: Retrospective study | |
| 36-month follow-up | Not described Receives: Other: Retrospective study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visit and Intravitreal Injection Numbers
The primary outcomes were changes in best-corrected visual acuity and central macular thickness in the first year and frequency of visits and intravitreal anti-VEGF injections.
Measured: First year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start29 Nov 2020
- Primary completion17 Mar 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 854 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levent Karabas, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472376
- Sponsor's protocol ID
- MARMASIA Study Group
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Outcomes of Anti-VEGF Treatment for Diabetic Macular Edema in Turkey: A Multicenter Retrospective Study, MARMASIA Study Group
- ClinicalTrials.gov ID
- NCT05472376
- Acronym / sponsor ID
- MARMASIA Study Group
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 854 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 29 Nov 2020 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 25 Jul 2022 (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.
The goal of this study is to evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in diabetic macular edema (DME) patients.
Detailed description
The study included patients who were being observed in the retina departments of 8 tertiary hospitals in the Northern Marmara Region of Turkey (Istanbul's Asian Side, Kocaeli, and Sakarya). The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018 were reviewed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 3-month follow-up | – | Other: Retrospective study |
| 6-month follow-up | – | Other: Retrospective study |
| 12-month follow-up | – | Other: Retrospective study |
| 24-month follow-up | – | Other: Retrospective study |
| 36-month follow-up | – | Other: Retrospective study |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018
Key inclusion criteria (2 listed)
- Diabetic macular edema treated with intravitreal anti-VEGF injection
- Having at least 4 or more annual examination visits
Key exclusion criteria (3 listed)
- Phacoemulsification surgery in the last 1 month
- PRFK / grid / focal / micropulse in the last 4 months
- Previous intraocular surgery (excluding PPV and phacoemulsification)
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 |
|---|---|---|
| Retrospective studyRetrospective study | Other | 12-month follow-up, 24-month follow-up, 3-month follow-up, 36-month follow-up, 6-month follow-up |
Primary outcome
Visit and Intravitreal Injection Numbers
Time frame: First year
The primary outcomes were changes in best-corrected visual acuity and central macular thickness in the first year and frequency of visits and intravitreal anti-VEGF injections.
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 25 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Kocaeli University at 10 sites in Turkey (Türkiye).
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 2 inclusion and 3 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 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Turkey (Türkiye). 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?
Visit and Intravitreal Injection Numbers (time frame: First 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 25 Jul 2022.