Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes

Diabetic Retinopathy Clinical Trial

— PROGRESS  

Official title:

PROGRESS - Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010397
• Other study ID #: IPM-2016
• Status: Completed
• Start date: December 2016
• Est. completion date: March 6, 2019

Study information

• Verified date: March 2020
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: March 6, 2019
• Est. primary completion date: January 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Locations

Country	Name	City	State
Portugal	Aibili-Cec	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phenotypic classification of DR in a 5-year period	Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)	5 years
Secondary	DR severity level	ETDRS grading	5 years
Secondary	Retinal thickness analysis	Retinal thickness (RT) in central subfield, inner and outer rings, assessed by SD-OCT and using layer-by-layer segmentation	5 years
Secondary	Ellipsoid zone analysis	Degree of integrity of the ellipsoid zone, assessed by SD-OCT	5 years
Secondary	Choroidal thickness analysis	Choroidal thickness assessed by Enhanced Depth Imaging (EDI) SD-OCT	5 years
Secondary	SD- OCT- Angiography analysis	Vessel analysis, assessed by SD-OCT OCT-Angiography	5 years
Secondary	OCT-Leakage analysis	LOR (low optical reflectivity) ratio in central subfield, inner and outer ring for assessment of BRB breakdown, assessed by OCT-Leakage	5 years
Secondary	Retinal thickness quantification	Retinal nerve fiber layer thickness (RNFL) and ganglion cells layer (GCL) + inner plexiform layer thickness (IPL) thickness, assessed by layer-by-layer SD-OCT	5 years
Secondary	mfERG assessement	P1 implicit time and P1 amplitude by ring	5 years