Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-23 @ 1:30 AM
Study NCT ID:
NCT03744767
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2018-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration
Sponsor:
Dr Irmela MANTEL
Organization:
Study Overview
Official Title:
Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: