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Spironolactone 50 mg for Diabetic Maculopathy

Phase 4
Waitlist Available
Led By Mark H Nelson, MD MBA
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This study is evaluating whether a medication called spironolactone may help improve vision for individuals with diabetic macular edema.

Eligible Conditions
  • Diabetic Maculopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Macular Edema - Central Subgroup Thickening
Macular Edema - Volume
Proportion of eyes with complete reabsorption of intraretinal fluid
+1 more
Secondary outcome measures
Extrafoveal exudation (nCST)

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089
8%
Hypotension
5%
Diabetes related
5%
Hyperkalemia
5%
Infection
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
3%
Surgical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Spironolactone TreatmentExperimental Treatment1 Intervention
Patients with non-responsive Diabetic Macular Edema will be treated with Spironolactone in addition to the regular course of monthly aflibercept (Eylea).

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,255 Total Patients Enrolled
Mark H Nelson, MD MBAPrincipal InvestigatorWake Forest University Health Sciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Non-Responsive Diabetic Macular Edema and Spironolactone
2022. "Non-Responsive Diabetic Macular Edema and Spironolactone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04853355.
~0 spots leftby Apr 2025
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