Clinical trial NCT01145599: Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures
Official title: Identifying Progression of Retinal Disease in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Non Proliferative Diabetic Retinopathy
Lead sponsor: European Vision Institute Clinical Research Network
Sponsor class: NETWORK
First posted: 2010-06-16
Enrollment: 374
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type-2 diabetes, NPDR

Brief summary: The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).

Detailed description: To identify "progressors" in retinal vascular disease and central retinal edema in type 2 diabetic patients with early NPDR, based on retinal disease progression from baseline to the 12-month visit, assessed by the following biomarkers:

* Microaneurysms turnover (MA formation rate over or equal to 2, i.e. number of new MA from baseline to the 12-month visit) computed from color fundus photographs using the RetmarkerDR software; and
* Retinal thickness increase in eyes with retinal thickening (Increase in retinal thickness above normal range) in the central subfield, the inner ring and/or the outer ring Constantly Present, Present or Absent (as measured by OCT and considering the macula thickness normative data.

Eligibility criteria: Inclusion Criteria:

1. Diabetes type 2 according to 1985 WHO criteria
2. Age between 35 and 75 years
3. Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography
4. Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2
5. Best Corrected Visual Acuity \>= 75 letters (\>= 20 /32)
6. Refraction with a spherical equivalent less than 5 Dp
7. Informed consent

Exclusion Criteria:

1. Cataract or other eye disease that may interfere with fundus examinations
2. Glaucoma
3. Any eye surgery within a period of 6-months
4. Other retinal vascular disease
5. Previous laser therapy
6. Dilatation of the pupil \< 5 mm

Primary outcomes:
measure: Identify "progressors"
timeFrame: 12 months
Secondary outcomes:
measure: Identify correlations between "progressors" and study outcomes.
timeFrame: 12 months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: José Cunha-Vaz, MD PhD
role: STUDY_CHAIR
References:
citation: Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.
citation: Cunha-Vaz J, Santos T, Ribeiro L, Alves D, Marques I, Goldberg M. OCT-Leakage: A New Method to Identify and Locate Abnormal Fluid Accumulation in Diabetic Retinal Edema. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6776-6783. doi: 10.1167/iovs.16-19999.
citation: Ribeiro L, Bandello F, Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets E, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Neves C, Cunha-Vaz J; Evicr Net Study Group. Characterization of Retinal Disease Progression in a 1-Year Longitudinal Study of Eyes With Mild Nonproliferative Retinopathy in Diabetes Type 2. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5698-705. doi: 10.1167/iovs.15-16708.
citation: Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets E, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Bandello F, Cunha-Vaz J; for EVICR.net. One-year progression of diabetic subclinical macular edema in eyes with mild nonproliferative diabetic retinopathy: location of the increase in retinal thickness. Ophthalmic Res. 2015;54(3):118-23. doi: 10.1159/000438793. Epub 2015 Aug 21.
citation: Bandello F, Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets RM, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Cunha-Vaz J; EVICR.net. Retinal layer location of increased retinal thickness in eyes with subclinical and clinical macular edema in diabetes type 2. Ophthalmic Res. 2015;54(3):112-7. doi: 10.1159/000438792. Epub 2015 Aug 21.