To identify eyes that show worsening and disease progression (progressor phenotypes). Primary ObjectiveTo identify *progressors* in retinal vascular disease and central retinal edema in type 2 diabetic patients with early NPDR, based on retinal…
ID
Source
Brief title
Condition
- Diabetic complications
- Ocular haemorrhages and vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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, the following biomarkers will
be assessed:
* Microaneurysms turnover (MA formation rate more than 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, annex 18.4).
Secondary outcome
To identify correlations between *progressors* and study outcomes in order to
characterize eyes/patients that show worsening and are candidates for
relatively short term trials of early NPDR. The following study outcomes will
be assessed:
* MA turnover (MA formation and disappearance rates);
* retinal thickness changes in the central subfield; the inner ring and/or the
outer ring;
* BCVA changes;
* ETDRS step changes; and
* rescue treatment (laser)
Background summary
The rate of progression of diabetic retinopathy varies widely between different
patients, even with similar metabolic control [Cunha-Vaz, Prog Retin. Eye Res.
2005]. It is becoming clear that a large percentage of patients with mild NPDR
will take a long time to develop any sight-threatening complication. The
inclusion of eyes/patients in a clinical trial that do not show any significant
worsening during the period of the trial masks any beneficial effect of the
drug being tested. It appears that the only option is to identify the
eyes/patients that show progression of retinopathy during a pre-trial run-in
period and only include such patients. Characterization of progressor
phenotypes in the early stages of diabetic retinopathy and identification of
biomarkers of disease progression are also objectives of major interest.
Study objective
To identify eyes that show worsening and disease progression (progressor
phenotypes).
Primary Objective
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.
Secondary Objective(s)
To identify correlations between *progressors* and study outcomes in order to
characterize eyes/patients that show worsening and are candidates for
relatively short term trials of early NPDR.
Study design
Observational study with a follow-up at 0, 3, 6 and 12 months in eyes with mild
NPDR with: laboratory tests (HbA1C levels), vital signs assessment (Blood
Pressure), color fundus photography, retinal thickness and BCVA.
Color fundus photographs will be analyzed with the RetmarkerDR software for the
automated assessment of microaneurysms turnover (MA formation and disappearance
rate).
Retinal thickness will be measured with Frequency Domain Optical Coherence
Tomography (FD-OCT).
Patients who signed informed consent will be evaluate for eligibility at
screening. If patient*s eligibility is confirmed, patients will be included in
the study and followed for the next 12 months.
Only one eye per patient will be considered for the study (Study Eye). If both
eyes meet the inclusion criteria the study eye will be chosen alternatively by
selecting the Right or the Left eye.
Study burden and risks
Within this study eyes will be examined with non-invasive methods. Besides the
burden of the time it takes to examine the patient, there are no other risks
involved.
Mydriatic drops will be instilled that can temporarily cause a slight decrease
in vision.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Diabetes Type 2 according to 1985 WHO criteria, Age between 35 and 75 years, mild non-proliferative diabetic retinopathy (levels 20 or 35 based on the ETDRS criteria) 7 field color fundus photography, Presence of at least 1 microaneurysm in the central 3000 micrometer area (corresponding to 2 DA) Field 2, Best corrected visual acuity better than or equal to 75 letters (20/32), Refraction with a spherical equivalent less than 5 Dp, Informed consent
Exclusion criteria
Cataract or other eye disease that may interfere with fundus examinations, Glaucoma, Any eye surgery within a period of 6 months, other retinal vascular disease, previous laser therapy, dilatation of the pupil < 5 mm
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01145599 |
| CCMO | NL36004.018.11 |