Aqueous Humor and Imaging Analysis from DME, nAMD and Cataract Patients

Recruiting

Conditions: diabetic macular edema
exsudative macular degeneration
10047060

Registration Number: NL-OMON54963

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 300

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* To establish values for AH biomarker composition in participants with nAMD or<br /><br>DME </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To establish normative baseline values for AH biomarker composition from<br /><br>cataract participants undergoing surgery with no vision impacting retinal<br /><br>pathology<br /><br>* Establish clusters of differentially expressed (vs healthy) AH biomarkers by<br /><br>pathways, including but not limited to angiogenesis, inflammation, apoptosis<br /><br>and fibrosis<br /><br>* To identify and segment disease phenotypes and grade disease severity in DME<br /><br>/ nAMD patients from their multi-modal imaging<br /><br>* To utilize advanced analytics to correlate AH biomarker signatures with<br /><br>disease morphology, disease phenotypes and severity<br /><br>* For treatment naïve patients: associate longitudinal AH and imaging<br /><br>biomarkers to model and predict treatment response<br /><br>* To explore correlations between disease, disease status, treatment response<br /><br>and disease relevant genetic polymorphisms</p><br>