Retinal Ischemia Characterization in Diabetes - "RICHARD"

NCT05112445 | Completed

• 1 other identifier: 4C-2021-10
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Retinal ischemia characterization in diabetes - RICHARD

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

• OCTA metrics and predict progression to PDR and/ or CI- DME

  Identify which baseline OCTA metrics and predict progression to PDR and/ or CI- DME best correlate with visual function.

  Change from baseline to Month 12

• OCTA metrics and predict progression to PDR and/ or CI- DME

  Identify which baseline OCTA metrics and predict progression to PDR and/ or CI- DME best correlate with visual function.

  Change from baseline to Month 24

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 individuals with type 2 diabetes and diabetic retinopathy with ETDRS DRSS grade 43 with IRMA, 47 or 53, with or without previous treatment, will be included in this study, over a recruitment period of 12 months.

You may qualify if:

• Diabetes type 2 according to 1985 WHO definition.
• Age over 18 years old.
• NPDR levels ETDRS DRSS (43 with IRMA, 47 or 53), based on the ETDRS criteria - 7 fields CFP and UWF FFA for 43 with IRMA after confirmation by the Reading Centre (CORC).
• Refraction with a spherical equivalent less than 5 diopters
• Able to provide informed consent.

You may not qualify if:

• Presence of diabetic macular edema (DME) involving the center of the macula in the study eye and needing immediate treatment.
• Presence of CI-DME defined as central subfield thickness on OCT ≥305 µm if male or ≥290 µm if female on Zeiss Cirrus OCT \[12\] with vision loss and needing immediate treatment.
• Cataract or other eye disease that may interfere with fundus examinations or OCT/OCTA signal strength.
• Age-related macular degeneration, glaucoma, vitreomacular disease, other retinal vascular disease, or any ocular condition that, in the opinion of the investigator may affect retinopathy status or alter VA during the study.
• Any eye surgery, including laser, and anti-VEGF within a period of 6-months.
• Dilatation of the pupil \> 5 mm.

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

AIBILI-CEC (AIBILI- Clinical Trials Centre)

Coimbra, 3000-548, Portugal

Location

Related Publications (2)

• Marques IP, Reste-Ferreira D, Santos T, Mendes L, Martinho AC, Yamaguchi TCN, Santos AR, Pearce E, Cunha-Vaz J. Progression of Capillary Hypoperfusion in Advanced Stages of Nonproliferative Diabetic Retinopathy: 6-month Analysis of RICHARD Study. Ophthalmol Sci. 2024 Oct 16;5(2):100632. doi: 10.1016/j.xops.2024.100632. eCollection 2025 Mar-Apr.

  PMID: 39639890 DERIVED

• Santos AR, Lopes M, Santos T, Reste-Ferreira D, Marques IP, Yamaguchi TCN, Miranda T, Mendes L, Martinho ACV, Pearce L, Cunha-Vaz J. Intraretinal Microvascular Abnormalities in Eyes with Advanced Stages of Nonproliferative Diabetic Retinopathy: Comparison Between UWF-FFA, CFP, and OCTA-The RICHARD Study. Ophthalmol Ther. 2024 Dec;13(12):3161-3173. doi: 10.1007/s40123-024-01054-2. Epub 2024 Oct 26.

  PMID: 39460896 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 8, 2021
• Study Start: March 30, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

PT (1)