Overview

Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration

Status:
Completed
Trial end date:
2015-09-22
Target enrollment:
0
Participant gender:
All
Summary
Prospective, non-comparative, mono-center pilot study. Patients with neovascular age-related macular degeneration (nAMD), responding insufficiently to the maximal standard care with monthly intravitreal anti-VEGF injections are given adjuvant oral mineralocorticoid receptor antagonists for 4 months and observed for any changes in vision or retinal structure during the 4 months of adjuvant treatment, plus 2 additional months without adjuvant treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dr Irmela MANTEL
Treatments:
Bevacizumab
Mineralocorticoids
Spironolactone
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