Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03744767
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of neovascular age-related macular degeneration, as confirmed on angiography by a retinal specialist (IM or AA)
* Aged more than 50 years (inherent to AMD)
* Unresponsive to maximal (monthly) anti-VEFG treatment (Ranibizumab or Aflibercept) for at least 6 months: persistant intra- or subretinal fluid on spectral domain optical coherence tomography at each visit 1 month after last injection.
* Treatment with anti-VEGF for nAMD for at least 12 months
* No contra-indications for adjunctive Spironolactone treatment
Exclusion Criteria:
* Confounding retinal pathology eg. myopic chorioretinopathy, diabetic retinopathy, vascular occlusion, retinal dystrophy and other retinal pathology
* Polypoidal choroidal vasculopathy
* Vitreomacular traction
* Poor quality OCT (image quality does not allow the grading / measures on OCT)
* High arterial pressure (\>160/100)
* K+\>5.0 mmol/l at baseline
* Na+ \<135 mmol/l at baseline
* Creatinine clearance under 30mL/min (calculation : coefficient\*(140-age)\*weight/creatinine in the serum; coefficient = 1.23 for males and 1.04 for females)
* Acute renal failure
* Renal dialysis
* Non-specified renal problem
* Arrhythmia
* Cardiovascular comorbidity with thromboembolic risk
* Known hypersensitivity to Spironolactone
* Ongoing medication with eplerenone (Inspra®)
* Decompensated hepatic cirrhosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03744767
Study Brief:
Protocol Section:
NCT03744767