Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome

NCT05080803 | Completed FDA Drug

• 1 other identifier: ESASO
• Study Type: observational
• Target: 608
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edema; ESASO Classification; Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Four months

Secondary Outcomes (1)

• Validation of ESASO DME staging classification

  3 months

Study Arms (4)

Early DME

Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately

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

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

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

Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Interventions

intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone DRUG

intravitreal administration

Advanced DME; Atrophic diabetic maculopathy; Early DME; Severe DME

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Any stage of DME treated with a loading dose of 3 anti-VEGF (any type) or 1 IV dexamethasone (STEP 1).
• OCT scans and retinal maps (radial/raster lines) at baseline (max 1 month before injection) and at one month (max 6 weeks) after the third anti-VEGF or at 3 months (max 16 weeks) after IV steroid injection (STEP 2).
• VA at the time of both OCT examinations.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European School of Advanced Studies in Ophthalmology: lead

Study Sites (1)

ESASO Scientific Projects

Lugano, CH-6901, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 31718271 BACKGROUND

• Panozzo 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.

  PMID: 34345028 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: October 18, 2021
• Study Start: June 1, 2021
• Primary Completion: December 23, 2021
• Study Completion: July 26, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)