The aim of this research is to study several important biomarkers of patients with diabetic macular edema and exsudative macular degeneration. Biomarkers are biological characteristics in the body (such as substances, structures and processes) that…
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* To establish values for AH biomarker composition in participants with nAMD or
DME
Secondary outcome
* To establish normative baseline values for AH biomarker composition from
cataract participants undergoing surgery with no vision impacting retinal
pathology
* Establish clusters of differentially expressed (vs healthy) AH biomarkers by
pathways, including but not limited to angiogenesis, inflammation, apoptosis
and fibrosis
* To identify and segment disease phenotypes and grade disease severity in DME
/ nAMD patients from their multi-modal imaging
* To utilize advanced analytics to correlate AH biomarker signatures with
disease morphology, disease phenotypes and severity
* For treatment naïve patients: associate longitudinal AH and imaging
biomarkers to model and predict treatment response
* To explore correlations between disease, disease status, treatment response
and disease relevant genetic polymorphisms
Background summary
In patients with exsudative macular degeneration, abnormal blood vessels form
in the macula (the location of the sharpest vision of the retina). These leak
more than normal blood vessels, which can lead to leakage and swelling. If the
abnormal blood vessels are left untreated, scar tissue will form in the macula.
All of these factors are associated with a deterioration in vision.
Diabetic macular edema can develop as part of retinal damage from diabetes
mellitus. The high blood sugar levels damage small blood vessels, making them
more permeable. As a result, leakage and swelling in the macula can also occur,
which can lead to visionloss.
By collecting biomarkers, the underlying disease (diabetic macular edema and
wet macular degeneration) can better be understood.
Study objective
The aim of this research is to study several important biomarkers of patients
with diabetic macular edema and exsudative macular degeneration. Biomarkers are
biological characteristics in the body (such as substances, structures and
processes) that can be determined to investigate the course, treatment of the
disease and how the body responds to treatment. Examples of biomarkers are
proteins in the blood, expression of genes (DNA), and certain characteristics
in imaging studies. These biomarkers are compared with biomarkers of cataract
patients.
Biomarkers are obtained from aqueous humour and blood, an attempt is made to
link them to biomarkers of the retinal images. Hereby, the underlying condition
can be better understood and a tailor-made treatment can be developed. In
addition, these data may lead to the discovery of new proteins or other
biomarkers that are important in these conditions, leading to the development
of new treatments.
Study design
It is an observational study.
Study burden and risks
There will be one visit of approximately 2 hours. For treatment-naïve patients,
there will be two visits of approximately 2 hours.
A paracentesis will be performed. Complications due to this procedure are rare.
Furthermore, one bloodsample will be collected.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. Able and willing to provide written informed consent. Alternatively, a
legally authorized representative must be able to consent for the patient.
2. Participants where sampling of >90 µl of AH seems feasible and safe in the
opinion of the investigator.
3. Male and female participants aged *18 years for DME participants or * 50
years for nAMD participants or aged * 45 years with age-related cataract
(scheduled for cataract surgery)
4. Clear ocular media and adequate pupillary dilation to allow acquisition of
good quality retinal imaging
5. DME and nAMD patients with treatment naïve, or ongoing treatment with
anti-VEGF
Exclusion criteria
1. Ocular history of retinal (focal-, pan- or macular) laser photocoagulation
within the last 3 months in study eye (in AMD: participants with a history of
central macular laser photocoagulation in the study eye are not permitted)
2. History of laser iridotomy or YAG laser capsulotomy within the last month in
study eye
3. History of vitreoretinal surgery/pars plana vitrectomy in study eye
4. Uncontrolled glaucoma or ocular hypertension * 25 mmHg in study eye
5. Neovascularization of the iris at screening in study eye
6. Participants affected by any systemic autoimmune disease
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 |
|---|---|
| CCMO | NL74634.018.20 |