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Clinical Trial Summary

Retinal ischemia characterization in diabetes - RICHARD

Clinical Trial Description

RICHARD is a non-interventional observational cross-sectional and prospective study. Patients will attend their routine clinical appointments, with 2-years of follow-up. Type 2 diabetic individuals with retinopathy ETDRS DRSS grade 43 with IRMA or grade 47-53 will be recruited and examined using non-invasive methodologies. The study will be performed at AIBILI Clinical Trials Centre (CEC). Demographic and systemic parameters, such as diabetes duration, medical history, medication, body mass index, and family history of medical conditions (particularly when related to cognitive decline) will be registered at baseline. All subjects will undergo an annual complete non-invasive ophthalmological examination, which includes, best corrected visual acuity, 7-fields CFP to assess ETDRS DRSS level, structural SD-OCT, SD-OCTA, SS-OCTA and ultra-widefield fundus photography (UWF FP). An invasive ophthalmological examination, the Ultra-wide field fundus fluorescein angiography (UWF FFA) will be obtained from both eyes at baseline (V0, M0) only in subjects with ETDRS DRSS grade 43 for final eligibility (43+IRMA). Ophthalmological examinations performed will be analyzed at AIBILI Coimbra Ophthalmology Reading Centre (CORC) and Centre for New Technologies e Medicine (CNTM). Color fundus photography (7-fields) will be acquired at V0 (month 0, baseline, cross-sectional study), V2 (month 12) and V3 (month 24), and then graded and classified according to the ETDRS severity scale by CORC, to allow evaluation of retinopathy progression over two years of follow-up. . At baseline visit (V0) both eyes will be evaluated and the study eye will be selected according to ETDRS DRSS grade (43 with IRMA, 47 or 53). Only the study eye will be considered for the primary statistical analysis; other statistical analyses will include both eyes. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05112445
Study type Observational [Patient Registry]
Source Association for Innovation and Biomedical Research on Light and Image
Contact Ana M Ferreira, MsC
Phone +351 239 480 137
Email [email protected]
Status Not yet recruiting
Start date March 2022
Completion date August 14, 2024

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