Clinical trial NCT03010397: Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes
Official title: PROGRESS - Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 212
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patients followed under the normal clinical practice at AIBILI Clinical Trial Centre.

- Type 2 diabetes mellitus according to 1985 WHO criteria

Brief summary: Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes (PROGRESS)

Detailed description: The global aim of this study is to improve the current knowledge of diabetic retinopathy (DR) progression. We aim to characterize both functionally and morphologically initial DR stages and to identify patients at risk of progression to centre involving macular oedema (CME) and/or proliferative diabetic retinopathy (PDR). We want to identify imaging patterns and characteristics that might be used as prognostic biomarkers for DR progression.

For this, ischemia and blood-retinal barrier alteration will be assessed using non-invasive retinal imaging methodologies. SD-OCT with layer-by-layer segmentation will be performed. Furthermore, a state-of-the-art methodology with OCT-Angiography will be used for identification of areas of capillary drop-out and leakage areas will be identified on SD-OCT without the need of a dye injection. In a subgroup of patients we will study neurodegeneration patterns using multifocal ERG examination.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus according to 1985 WHO criteria
* Aged between 35 years and 80 at baseline in the retrospective period
* NPDR level \< 20 (MA absent) or Mild NPDR (levels 20 to 35, based on ETDRS criteria- 7 fields CFP) at baseline
* BCVA ≥ 75 letters (≥ 20/32) at baseline (ETDRS charts)
* Informed Consent

Exclusion Criteria:

* Inadequate ocular media and/ or pupil dilatation that interfere with fundus examinations
* HbA1C \> 10 % at the Screening or previous 6 months in the previous prospective study

Primary outcomes:
measure: Phenotypic classification of DR in a 5-year period
timeFrame: 5 years
Secondary outcomes:
measure: DR severity level
timeFrame: 5 years
measure: Retinal thickness analysis
timeFrame: 5 years
measure: Ellipsoid zone analysis
timeFrame: 5 years
measure: Choroidal thickness analysis
timeFrame: 5 years
measure: SD- OCT- Angiography analysis
timeFrame: 5 years
measure: OCT-Leakage analysis
timeFrame: 5 years
measure: Retinal thickness quantification
timeFrame: 5 years
measure: mfERG assessement
timeFrame: 5 years
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Aibili-Cec
Study officials:
References:
citation: Martinho AC, Marques IP, Messias AL, Santos T, Madeira MH, Sousa DC, Lobo C, Cunha-Vaz J. Ocular and Systemic Risk Markers for Development of Macular Edema and Proliferative Retinopathy in Type 2 Diabetes: A 5-Year Longitudinal Study. Diabetes Care. 2021 Jan;44(1):e12-e14. doi: 10.2337/dc20-1125. Epub 2020 Nov 6. No abstract available.
citation: Marques IP, Alves D, Santos T, Mendes L, Santos AR, Lobo C, Durbin M, Cunha-Vaz J. Multimodal Imaging of the Initial Stages of Diabetic Retinopathy: Different Disease Pathways in Different Patients. Diabetes. 2019 Mar;68(3):648-653. doi: 10.2337/db18-1077. Epub 2018 Dec 6.