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

NCT03744767 | Completed Phase 2

• 1 other identifier: 184/14
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Retinal thickness change

  retinal thickness in micrometers measured from the internal limiting membrane (ILM) to Bruch's membrane on optical coherence tomography

  Month 3, Month 6

Secondary Outcomes (8)

• Best-corrected visual acuity

  Month 3, Month 6

• central retinal thickness

  Month 3, Month 6

• central retinal volume

  Month 3, Month 6

• foveal retinal thickness

  Month 3, Month 6

• maximum neuroretinal thickness with cystic changes

  Month 3, Month 6

Study Arms (1)

Single treatment arm

EXPERIMENTAL

Drug: Spironolactone 50 MG

Interventions

Spironolactone 50 MG DRUG

oral administration of Spironolactone, 25mg daily for 1 week, then 50mg daily until visit Month 3, followed by 25mg daily from visit Month 3 to visit Month 4

Single treatment arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®)

Sponsors & Collaborators

• Dr Irmela MANTEL: lead

MeSH Terms

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lead consultant, Head of the medical retina service, Principal Investigator, Privatdocent

Model Details: all participants receive fixed monthly intravitreal anti-VEGF injections for 6 months, plus adjuvant treatment during 4 months, followed by 2 months without adjuvant treatment.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: September 19, 2014
• Primary Completion: September 22, 2015
• Study Completion: September 22, 2015
• Last Updated: November 16, 2018

Record last verified: 2018-11