Diabetic RetinopathyRICHARDNCT05112445
Retinal Ischemia Characterization in Diabetes - "RICHARD"
An observational study of Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
Trial summary
Retinal ischemia characterization in diabetes - RICHARD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Mar 2022to 30 Apr 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
- HbA1c > 12% in the last measurement prior to the study visit (V0). Study Eye: Only one eye per subject will be considered for the primary statistical analysis (Study Eye). If both eyes meet the inclusion criteria the study eye will be the one that has a higher level of DR (ETDRS classification). If both eyes have the same ETDRS DRSS grading, the eye with higher BCVA will be chosen. If both eyes have the same BCVA, the right eye will be chosen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retinal Ischemia Characterization in Diabetes.
Retinal ischemia characterization in diabetes - RICHARD
Read the detailed 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.
- Conditions
- Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start30 Mar 2022
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112445
- Sponsor's protocol ID
- 4C-2021-10
- Acronym
- RICHARD
- Status last verified
- May 2026
- First submitted
- 20 Oct 2021
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39639890Santos 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.
PubMed 39460896
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Ischemia Characterization in Diabetes.
- ClinicalTrials.gov ID
- NCT05112445
- Acronym / sponsor ID
- RICHARD / 4C-2021-10
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retinal ischemia characterization in diabetes - RICHARD
Detailed 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OCTA metrics and predict progression to PDR and/ or CI- DME
Time frame: Change from baseline to Month 12
Identify which baseline OCTA metrics and predict progression to PDR and/ or CI- DME best correlate with visual function.
OCTA metrics and predict progression to PDR and/ or CI- DME
Time frame: Change from baseline to Month 24
Identify which baseline OCTA metrics and predict progression to PDR and/ or CI- DME best correlate with visual function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 39639890Marques 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.
- Derived from this study: PubMed 39460896Santos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCTA metrics and predict progression to PDR and/ or CI- DME (time frame: Change from baseline to Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05112445, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.