Neovascular Age-related Macular Degeneration Clinical Trial
Official title:
Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration
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.
Hypothesis Systemic anti-Mineralocorticoid-Receptor treatment may be a valuable adjuvant
treatment in anti-VEGF refractory nAMD, potentially allowing for better absorption of the
exudative fluid.
Aim To estimate the effect of systemic anti-Mineralocorticoid-Receptor treatment on eyes with
nAMD which have remained exudative despite monthly anti-VEGF treatment for at least 6 months
prior to enrolment.
Objectives Primary objective
- To calculate the changes induced in retinal thickness following adjunct systemic
anti-Mineralocorticoid-Receptor treatment Secondary objective
- To calculate the changes induced following adjunct systemic
anti-Mineralocorticoid-Receptor treatment in the following ocular parameters
- Thickness of the neuro-retina (foveal)
- Amount of subretinal fluid (foveal and highest elevation)
- Height of retinal pigment epithelium detachment (foveal and highest elevation)
- Central (Subfoveal) choroidal thickness, and at 500um nasal and temporal to the
fovea
- Presence / absence of exudative signs on OCT, according to the type of fluid
(intraretinal cysts, subretinal fluid)
- Best corrected visual acuity (number of letters)
Medications:
Standard medical treatment (monthly intravitreal injections with anti-VEGF) will be continued
during this trial, no current medications will be altered. The medication spironolactone, an
MR antagonist will be added to the currently prescribed medications (phase IV). The standard
dose of 50mg once daily per os will be prescribed for 3 months (first week 25mg only for
treatment introduction and safety), tapered during month 4 (25mg once daily).
In the case of a patient current taking a medication with contra-indications for this drug,
then the conflicting medication will be exchanged for an equivalent treatment option, where
this is not possible then these patients will be excluded from the study. The patient will be
withdrawn from the study in case of any serious side effects attributable to spironolactone
(increased K+ above 5.5mmol/l).
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