Neovascular Age-related Macular DegenerationPhase 2NCT03744767
Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration
A Phase 2 study testing Spironolactone 50 MG in people with Neovascular Age-related Macular Degeneration, run by Dr Irmela MANTEL.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Spironolactone 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 19 Sep 2014to 22 Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
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.
Read the 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).
- Being tested
- Spironolactone 50 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone 50 MGDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Single treatment arm | Experimental | Not described Receives: Drug: Spironolactone 50 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness change
retinal thickness in micrometers measured from the internal limiting membrane (ILM) to Bruch's membrane on optical coherence tomography
Measured: Month 3, Month 6
Secondary outcomes (8)
Best-corrected visual acuity
on ETDRS chart
Measured: Month 3, Month 6
central retinal thickness
automatic values from SD-OCT after segmentation correction, in micrometers
Measured: Month 3, Month 6
central retinal volume
automatic values from SD-OCT after segmentation correction
Measured: Month 3, Month 6
foveal retinal thickness
manual measurement in micrometers from ILM to Bruch membrane at the fovea
Measured: Month 3, Month 6
maximum neuroretinal thickness with cystic changes
manual measure in micrometers from ILM to outer segments of photoreceptors
Measured: Month 3, Month 6
subretinal fluid thickness
manual measure in micrometers between outer segment layer and pigment epithelium
Measured: Month 3, Month 6
pigment epithelium detachment height
manual measure in micrometers from the RPE layer to Bruch's membrane
Measured: Month 3, Month 6
subfoveal choroidal thickness
manual measure in micrometers on enhanced depth OCT imaging
Measured: Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start19 Sep 2014
- Primary completion22 Sep 2015
- Study completion22 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Irmela MANTEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Irmela MANTEL, Eye Hospital Jules Gonin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744767
- Sponsor's protocol ID
- 184/14
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03744767
- Acronym / sponsor ID
- 184/14
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr Irmela MANTELUniversity, hospital or other
- Study start
- 19 Sep 2014 (actual)
- Primary completion
- 22 Sep 2015 (actual)
- Study completion
- 22 Sep 2015 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single treatment arm | Experimental | Drug: Spironolactone 50 MG |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone 50 MGoral 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 | Drug | Single treatment arm |
Primary outcome
Retinal thickness change
Time frame: Month 3, Month 6
retinal thickness in micrometers measured from the internal limiting membrane (ILM) to Bruch's membrane on optical coherence tomography
8 secondary outcomes
Best-corrected visual acuity
Time frame: Month 3, Month 6
central retinal thickness
Time frame: Month 3, Month 6
central retinal volume
Time frame: Month 3, Month 6
foveal retinal thickness
Time frame: Month 3, Month 6
maximum neuroretinal thickness with cystic changes
Time frame: Month 3, Month 6
subretinal fluid thickness
Time frame: Month 3, Month 6
pigment epithelium detachment height
Time frame: Month 3, Month 6
subfoveal choroidal thickness
Time frame: Month 3, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolactone 50 MG in people with Neovascular Age-related Macular Degeneration, run by Dr Irmela MANTEL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal thickness change (time frame: Month 3, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.