Diabetic RetinopathyPROGRESSNCT03010397
Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes
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
Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes (PROGRESS) Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 212 participants
- Where
- 1 sitePortugal
- Study dates
- Dec 2016to 6 Mar 2019
- How long will I take part?
- 3 Years
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patients followed under the normal clinical practice at AIBILI Clinical Trial Centre. - Type 2 diabetes mellitus according to 1985 WHO criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROGRESS - Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes
Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes (PROGRESS)
Read the 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.
- 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.
Phenotypic classification of DR in a 5-year period
Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)
Measured: 5 years
Secondary outcomes (8)
DR severity level
ETDRS grading
Measured: 5 years
Retinal thickness analysis
Retinal thickness (RT) in central subfield, inner and outer rings, assessed by SD-OCT and using layer-by-layer segmentation
Measured: 5 years
Ellipsoid zone analysis
Degree of integrity of the ellipsoid zone, assessed by SD-OCT
Measured: 5 years
Choroidal thickness analysis
Choroidal thickness assessed by Enhanced Depth Imaging (EDI) SD-OCT
Measured: 5 years
SD- OCT- Angiography analysis
Vessel analysis, assessed by SD-OCT OCT-Angiography
Measured: 5 years
OCT-Leakage analysis
LOR (low optical reflectivity) ratio in central subfield, inner and outer ring for assessment of BRB breakdown, assessed by OCT-Leakage
Measured: 5 years
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
Measured: 5 years
mfERG assessement
P1 implicit time and P1 amplitude by ring
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion11 Jan 2017
- Study completion6 Mar 2019
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
- Prospective
- Enrolment
- 212 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010397
- Sponsor's protocol ID
- IPM-2016
- Acronym
- PROGRESS
- Status last verified
- Mar 2020
- First submitted
- 19 Sep 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33158947Marques 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.
PubMed 30523027
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROGRESS - Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes
- ClinicalTrials.gov ID
- NCT03010397
- Acronym / sponsor ID
- PROGRESS / IPM-2016
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 11 Jan 2017 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patients followed under the normal clinical practice at AIBILI Clinical Trial Centre. - Type 2 diabetes mellitus according to 1985 WHO criteria
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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
Phenotypic classification of DR in a 5-year period
Time frame: 5 years
Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)
8 secondary outcomes
DR severity level
Time frame: 5 years
Retinal thickness analysis
Time frame: 5 years
Ellipsoid zone analysis
Time frame: 5 years
Choroidal thickness analysis
Time frame: 5 years
SD- OCT- Angiography analysis
Time frame: 5 years
OCT-Leakage analysis
Time frame: 5 years
Retinal thickness quantification
Time frame: 5 years
mfERG assessement
Time frame: 5 years
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 24 Mar 2020.
- Derived from this study: PubMed 33158947Martinho 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.
- Derived from this study: PubMed 30523027Marques 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.
- Individual participant dataSharing planned: Yes
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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 2 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 24 Mar 2020. 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?
Phenotypic classification of DR in a 5-year period (time frame: 5 years). 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 NCT03010397, 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 24 Mar 2020.