Diabetic Macular EdemaNCT05080803
Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome
An observational study of Diabetic Macular Edema, run by European School of Advanced Studies in Ophthalmology at 1 site in Switzerland.
Trial summary
Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone
- How many people
- 608 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2021to 26 Jul 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 50 years and older
- All sexes
- Adult, Older adult
Study population: B. Major Eligibility Criteria 1. Age ≥ 50 years 2. Type 1 or type 2 diabetes 3. No history/presence of any other ocular/macular pathology 4. No history of IV/laser treatment in the past 8 months 5. No history of cataract or other ocular surgery in the past 6 months
Who may be able to join
None listed.
Who cannot join
- Past ocular surgery of any kind (except for cataract surgery) or ocular pathologies other than diabetic retinopathy.
- Macular edema considered to be due to a cause other than diabetic macular edema.
- OCT examination suggesting that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema. In the case of ERM, an OCT scan must be sent to the Coordinating Center for approval.
- Any ocular pathology or ocular condition other than diabetes that in the opinion of the investigator might affect macular edema.
- History of any therapy (anti-VEGF treatment, focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids) for DME or diabetic retinopathy in the past 8 months.
- History of YAG capsulotomy performed within two months before enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.
Read the detailed description
The ESASO morphologic classification of diabetic macular edema defines four stages of progression of the disease: early, advanced, chronic and atrophic maculopathy.
This grading is generated by the analysis of seven biomarkers that fully describe the level of retinal damage. Aim of this classification is to be a valid method for a comprehensive description of DME in scientific studies or clinical practice.
Given the recent publication of ESASO Classification, there aren't observations on the real relevance of grading DME on therapeutic outcome.
This retrospective study wants to give a preliminary answer to this important issue.
As a corollary outcome, this study will also evaluate the concordance of grading among participants.
- Conditions
- Diabetic Macular Edema
- Being tested
- intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone
- Keywords
- diabetic macular edema, ESASO Classification, Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazoneDrug
intravitreal administration
| Study group | Role | What they receive |
|---|---|---|
| Early DME | Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately Receives: Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone | |
| Advanced DME | Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately Receives: Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone | |
| Severe DME | Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately Receives: Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone | |
| Atrophic diabetic maculopathy | Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately Receives: Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease.
Visual acuity and morphological (OCT) stage of the disease (as described in ESASO DME classification) will be evaluated at time 0 and four months after the first injection of intravitreal dexamethasone or one month after the loading phase (3 monthly injections) with anti-VEGF.
Measured: Four months
Secondary outcomes (1)
Validation of ESASO DME staging classification
After preliminary instruction on ESASO Staging system of DME, participating centers will evaluate the stage of DME at time 0 of every eye retrospectically selected to participate to the study. This staging will be than validated by the Coordinating Center, and the total concordance of staging (K index) will be used to validate the Classification
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Jun 2021
- Primary completion23 Dec 2021
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- European School of Advanced Studies in Ophthalmology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080803
- Sponsor's protocol ID
- ESASO
- Status last verified
- Sep 2023
- First submitted
- 11 Aug 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Panozzo G, Cicinelli MV, Augustin AJ, Battaglia Parodi M, Cunha-Vaz J, Guarnaccia G, Kodjikian L, Jampol LM, Junemann A, Lanzetta P, Lowenstein A, Midena E, Navarro R, Querques G, Ricci F, Schmidt-Erfurth U, Silva RMD, Sivaprasad S, Varano M, Virgili G, Bandello F. An optical coherence tomography-based grading of diabetic maculopathy proposed by an international expert panel: The European School for Advanced Studies in Ophthalmology classification. Eur J Ophthalmol. 2020 Jan;30(1):8-18. doi: 10.1177/1120672119880394. Epub 2019 Nov 12.
PubMed 31718271Panozzo G, Mura GD, Franzolin E, Giannarelli D, Albano V, Alessio G, Arrigo A, Casati S, Cassottana P, Contardi C, D'Aloisio R, Fasce F, Gusson E, Marchini G, Mastropasqua L, Niccolo M, Palmisano C, Pastore MR, Saviano S, Tognetto D, Bandello F. Early DMO: a predictor of poor outcomes following cataract surgery in diabetic patients. The DICAT-II study. Eye (Lond). 2022 Aug;36(8):1687-1693. doi: 10.1038/s41433-021-01718-4. Epub 2021 Aug 3.
PubMed 34345028
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome
- ClinicalTrials.gov ID
- NCT05080803
- Acronym / sponsor ID
- ESASO
- Conditions
- Diabetic Macular Edema
- Keywords
- diabetic macular edema, ESASO Classification, Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- European School of Advanced Studies in OphthalmologyUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 18 Oct 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.
Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.
Detailed description
The ESASO morphologic classification of diabetic macular edema defines four stages of progression of the disease: early, advanced, chronic and atrophic maculopathy.
This grading is generated by the analysis of seven biomarkers that fully describe the level of retinal damage. Aim of this classification is to be a valid method for a comprehensive description of DME in scientific studies or clinical practice.
Given the recent publication of ESASO Classification, there aren't observations on the real relevance of grading DME on therapeutic outcome.
This retrospective study wants to give a preliminary answer to this important issue.
As a corollary outcome, this study will also evaluate the concordance of grading among participants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early DME | – | Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazoneFunctional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately |
| Advanced DME | – | Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazoneFunctional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately |
| Severe DME | – | Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazoneFunctional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately |
| Atrophic diabetic maculopathy | – | Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazoneFunctional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- B. Major Eligibility Criteria 1. Age ≥ 50 years 2. Type 1 or type 2 diabetes 3. No history/presence of any other ocular/macular pathology 4. No history of IV/laser treatment in the past 8 months 5. No history of cataract or other ocular surgery in the past 6 months
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Past ocular surgery of any kind (except for cataract surgery) or ocular pathologies other than diabetic retinopathy.
- Macular edema considered to be due to a cause other than diabetic macular edema.
- OCT examination suggesting that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema. In the case of ERM, an OCT scan must be sent to the Coordinating Center for approval.
- Any ocular pathology or ocular condition other than diabetes that in the opinion of the investigator might affect macular edema.
- History of any therapy (anti-VEGF treatment, focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids) for DME or diabetic retinopathy in the past 8 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 |
|---|---|---|
| intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazoneintravitreal administration | Drug | Advanced DME, Atrophic diabetic maculopathy, Early DME, Severe DME |
Primary outcome
Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease.
Time frame: Four months
Visual acuity and morphological (OCT) stage of the disease (as described in ESASO DME classification) will be evaluated at time 0 and four months after the first injection of intravitreal dexamethasone or one month after the loading phase (3 monthly injections) with anti-VEGF.
1 secondary outcome
Validation of ESASO DME staging classification
Time frame: 3 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 28 Sep 2023.
- Background: PubMed 31718271Panozzo G, Cicinelli MV, Augustin AJ, Battaglia Parodi M, Cunha-Vaz J, Guarnaccia G, Kodjikian L, Jampol LM, Junemann A, Lanzetta P, Lowenstein A, Midena E, Navarro R, Querques G, Ricci F, Schmidt-Erfurth U, Silva RMD, Sivaprasad S, Varano M, Virgili G, Bandello F. An optical coherence tomography-based grading of diabetic maculopathy proposed by an international expert panel: The European School for Advanced Studies in Ophthalmology classification. Eur J Ophthalmol. 2020 Jan;30(1):8-18. doi: 10.1177/1120672119880394. Epub 2019 Nov 12.
- Background: PubMed 34345028Panozzo G, Mura GD, Franzolin E, Giannarelli D, Albano V, Alessio G, Arrigo A, Casati S, Cassottana P, Contardi C, D'Aloisio R, Fasce F, Gusson E, Marchini G, Mastropasqua L, Niccolo M, Palmisano C, Pastore MR, Saviano S, Tognetto D, Bandello F. Early DMO: a predictor of poor outcomes following cataract surgery in diabetic patients. The DICAT-II study. Eye (Lond). 2022 Aug;36(8):1687-1693. doi: 10.1038/s41433-021-01718-4. Epub 2021 Aug 3.
- 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 European School of Advanced Studies in Ophthalmology at 1 site in Switzerland.
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 0 inclusion and 6 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 28 Sep 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 Switzerland. 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?
Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease. (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080803, which also lists 2 linked publications.
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 28 Sep 2023.