Diabetic MaculopathyPhase 4NCT04853355
Non-Responsive Diabetic Macular Edema and Spironolactone
A Phase 4 study testing Spironolactone 50 mg in people with Diabetic Maculopathy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Diabetic patients with macular edema and choroidal hyperpermeability (as manifested as a thick choroid on OCT (optical coherence tomography) and ICG hyperfluorescence on ICG) unresponsive to anti-VEGF (vascular endothelial growth factor) and steroid injections will be treated with spironolactone in addition to the… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Maculopathy
- What is being tested?
- Spironolactone 50 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2022to Oct 2022
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of persistent Diabetic cystoid macular edema despite course of anti-VEGF injections and intraocular steroids. At the time of study baseline, the patients must be on q4 week intravitreal anti-VEGF medications and have failed (poor response - less than 50% decrease in macular central subfield thickness (CST) and volume) with intravitreal steroids (triamcinolone acetonide or dexamethasone implant).
- Evidence of pachychoroid (choroid greater than 300 microns on OCT - EDI) with pachyvessels on OCT or OCTA. In addition, ICG (Indocyanine Green Angiogram) must show evidence of hyperfluorescence.
- Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study (ETDRS).
- IOP ≤ 25 mmHg - Patients that screen fail due to elevated IOP ˃25 mmHg may rescreen once IOP is treated and within normal limits (≤25 mmHg).
Who cannot join
- Exudative maculopathies due to myopic choroidal degeneration, histoplasmosis, trauma, and specifically, the presence of angioid streaks.
- Myocardial infarction or cerebrovascular accident within the last 6 weeks
- Previous vitrectomy
- Hypokalemia
- Optic neuropathy
- Traction maculopathies
- Allergies to fluorescein and indocyanine, dilating agents, spironolactone, triamcinolone or anti-VEGF medications
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Non-Responsive Diabetic Macular Edema in Patients With Pachychoroid and Choroidal Hyperpermeability.
Diabetic patients with macular edema and choroidal hyperpermeability (as manifested as a thick choroid on OCT (optical coherence tomography) and ICG hyperfluorescence on ICG) unresponsive to anti-VEGF (vascular endothelial growth factor) and steroid injections will be treated with spironolactone in addition to the continued treatment of anti-VEGF injections, specifically aflibercept (Eylea).
Read the detailed description
This is a non-randomized, prospective study of 10 patients referred during the years 2018 to 2020 with the diagnosis of Diabetic Macular Edema. Each patient was noted to have pachychoroid, choroidal hyperpermeability, and most important resistant to multiple anti-VEGF and steroid intravitreal injections, and have moderate vision loss. In addition, despite the fact that we use anti-VEGF medications, we do not know the levels of VEGF in the eye, nor do we have an explanation for the inability to respond to these drugs. This study will determine the degree of VEGF concentrations, response to anti-VEGF treatments, and determine biomarkers of inflammation as a means for explaining the cause of treatment resistance. Subsequently, another pathological process will be treated with spironolactone to see if the degree of contribution of choroidal hyperpermeability to the exudative process.
- Conditions
- Diabetic Maculopathy
- Being tested
- Spironolactone 50 mg
- Keywords
- spironolactone, anti-VEGF injections, aflibercept, Eylea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone 50 mgDrug
Add Spironolactone 50 mg to previous regimen
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone Treatment | Experimental | Patients with non-responsive Diabetic Macular Edema will be treated with Spironolactone in addition to the regular course of monthly aflibercept (Eylea). Receives: Drug: Spironolactone 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes with complete reabsorption of intraretinal fluid
Measured: 1 year
Macular Edema - Central Subgroup Thickening
Measured: 1 year
Macular Edema - Volume
Macular volume
Measured: 1 year
Vision, best corrected, logMAR units
Measured: 1 year
Secondary outcomes (1)
Extrafoveal exudation (nCST)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study startJul 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic MaculopathyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark H Nelson, MD MBA, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853355
- Sponsor's protocol ID
- IRB00073697
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request.
Publications
Kim DY, Lee JY, Lee EK, Kim JY. COMPARISON OF VISUAL/ANATOMICAL OUTCOMES AND RECURRENCE RATE BETWEEN ORAL SPIRONOLACTONE AND PHOTODYNAMIC THERAPY FOR NONRESOLVING CENTRAL SEROUS CHORIORETINOPATHY. Retina. 2020 Jun;40(6):1191-1199. doi: 10.1097/IAE.0000000000002507.
PubMed 30897068
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Responsive Diabetic Macular Edema in Patients With Pachychoroid and Choroidal Hyperpermeability.
- ClinicalTrials.gov ID
- NCT04853355
- Acronym / sponsor ID
- IRB00073697
- Conditions
- Diabetic Maculopathy
- Keywords
- spironolactone, anti-VEGF injections, aflibercept, Eylea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 21 Apr 2021 (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.
Diabetic patients with macular edema and choroidal hyperpermeability (as manifested as a thick choroid on OCT (optical coherence tomography) and ICG hyperfluorescence on ICG) unresponsive to anti-VEGF (vascular endothelial growth factor) and steroid injections will be treated with spironolactone in addition to the continued treatment of anti-VEGF injections, specifically aflibercept (Eylea).
Detailed description
This is a non-randomized, prospective study of 10 patients referred during the years 2018 to 2020 with the diagnosis of Diabetic Macular Edema. Each patient was noted to have pachychoroid, choroidal hyperpermeability, and most important resistant to multiple anti-VEGF and steroid intravitreal injections, and have moderate vision loss. In addition, despite the fact that we use anti-VEGF medications, we do not know the levels of VEGF in the eye, nor do we have an explanation for the inability to respond to these drugs. This study will determine the degree of VEGF concentrations, response to anti-VEGF treatments, and determine biomarkers of inflammation as a means for explaining the cause of treatment resistance. Subsequently, another pathological process will be treated with spironolactone to see if the degree of contribution of choroidal hyperpermeability to the exudative process.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, pilot study
| Arm | Type | Receives |
|---|---|---|
| Spironolactone Treatment | Experimental | Drug: Spironolactone 50 mgPatients with non-responsive Diabetic Macular Edema will be treated with Spironolactone in addition to the regular course of monthly aflibercept (Eylea). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of persistent Diabetic cystoid macular edema despite course of anti-VEGF injections and intraocular steroids. At the time of study baseline, the patients must be on q4 week intravitreal anti-VEGF medications and have failed (poor response - less than 50% decrease in macular central subfield thickness (CST) and volume) with intravitreal steroids (triamcinolone acetonide or dexamethasone implant).
- Evidence of pachychoroid (choroid greater than 300 microns on OCT - EDI) with pachyvessels on OCT or OCTA. In addition, ICG (Indocyanine Green Angiogram) must show evidence of hyperfluorescence.
- Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study (ETDRS).
- IOP ≤ 25 mmHg - Patients that screen fail due to elevated IOP ˃25 mmHg may rescreen once IOP is treated and within normal limits (≤25 mmHg).
Key exclusion criteria (8 listed)
- Exudative maculopathies due to myopic choroidal degeneration, histoplasmosis, trauma, and specifically, the presence of angioid streaks.
- Myocardial infarction or cerebrovascular accident within the last 6 weeks
- Previous vitrectomy
- Hypokalemia
- Optic neuropathy
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 mgAdd Spironolactone 50 mg to previous regimen | Drug | Spironolactone Treatment |
Primary outcome
Proportion of eyes with complete reabsorption of intraretinal fluid
Time frame: 1 year
Macular Edema - Central Subgroup Thickening
Time frame: 1 year
Macular Edema - Volume
Time frame: 1 year
Macular volume
Vision, best corrected, logMAR units
Time frame: 1 year
1 secondary outcome
Extrafoveal exudation (nCST)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 30897068Kim DY, Lee JY, Lee EK, Kim JY. COMPARISON OF VISUAL/ANATOMICAL OUTCOMES AND RECURRENCE RATE BETWEEN ORAL SPIRONOLACTONE AND PHOTODYNAMIC THERAPY FOR NONRESOLVING CENTRAL SEROUS CHORIORETINOPATHY. Retina. 2020 Jun;40(6):1191-1199. doi: 10.1097/IAE.0000000000002507.
- Individual participant dataSharing planned: Yes. Available upon request.
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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.
Mark H Nelson, MD MBA principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone 50 mg in people with Diabetic Maculopathy, run by Wake Forest University Health Sciences at 1 site in United States.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of eyes with complete reabsorption of intraretinal fluid (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853355, which also lists 1 linked publication.
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 2 Aug 2022.