Diabetic Macular EdemaADMIRENCT05683912
Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece
An observational study of Diabetic Macular Edema, run by University of Athens at 1 site in Greece.
Trial summary
ADMIRE was a prospective, observational cohort study of patients with diabetic macular edema (DME). Efficacy was assessed by change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to months 12, 24 and 36 after treatment with intravitreal aflibercept in treatment-naïve patients… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Aflibercept
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2019to 15 Dec 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with DME treated with intravitreal aflibercept 2.0mg in routice clinical practice.
Who may be able to join
- Patients with DM, able to give written informed consent Patients with DME>320 μm, who need treatment
Who cannot join
- Patients with other retinal diseases than DME Intraocular surgery within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece: The ADMIRE Study
ADMIRE was a prospective, observational cohort study of patients with diabetic macular edema (DME). Efficacy was assessed by change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to months 12, 24 and 36 after treatment with intravitreal aflibercept in treatment-naïve patients and previously treated patients. Safety was evaluated by recording any patients-reported events.
- Conditions
- Diabetic Macular Edema
- Being tested
- Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Intravitreal aflibercept as used in the routice clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best-corrected visual acuity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Sep 2019
- Primary completion1 Sep 2021
- Study completion15 Dec 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irini Chatziralli, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683912
- Sponsor's protocol ID
- 698/2019
- Acronym
- ADMIRE
- Status last verified
- Dec 2022
- First submitted
- 27 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- 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 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece: The ADMIRE Study
- ClinicalTrials.gov ID
- NCT05683912
- Acronym / sponsor ID
- ADMIRE / 698/2019
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 13 Jan 2023 (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.
ADMIRE was a prospective, observational cohort study of patients with diabetic macular edema (DME). Efficacy was assessed by change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to months 12, 24 and 36 after treatment with intravitreal aflibercept in treatment-naïve patients and previously treated patients. Safety was evaluated by recording any patients-reported events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with DME treated with intravitreal aflibercept 2.0mg in routice clinical practice.
Key inclusion criteria (1 listed)
- Patients with DM, able to give written informed consent Patients with DME>320 μm, who need treatment
Key exclusion criteria (1 listed)
- Patients with other retinal diseases than DME Intraocular surgery within the last 6 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 |
|---|---|---|
| AfliberceptIntravitreal aflibercept as used in the routice clinical practice | Drug | – |
Primary outcome
Change in best-corrected visual acuity
Time frame: 12 months
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 13 Jan 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.
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?
An observational study of Diabetic Macular Edema, run by University of Athens at 1 site in Greece.
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 1 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 13 Jan 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 Greece. 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?
Change in best-corrected visual acuity (time frame: 12 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 13 Jan 2023.