Non-Responsive Diabetic Macular Edema and Spironolactone

Phase 4

Withdrawn

• Conditions: Diabetic Maculopathy
• Interventions: Drug: Spironolactone 50 mg

• Registration Number: NCT04853355
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Status Verified: 2022-04
• Study Start: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-02
• Primary Completion: 2022-09
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spironolactone Treatment	Spironolactone 50 mg	Patients with non-responsive Diabetic Macular Edema will be treated with Spironolactone in addition to the regular course of monthly aflibercept (Eylea).

Primary Outcome Measures

Name	Time	Method
Proportion of eyes with complete reabsorption of intraretinal fluid	1 year
Macular Edema - Volume	1 year	Macular volume
Macular Edema - Central Subgroup Thickening	1 year
Vision, best corrected, logMAR units	1 year

Secondary Outcome Measures

Name	Time	Method
Extrafoveal exudation (nCST)	1 year

Trial Locations

Locations (1)

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States