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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
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial tests if adding spironolactone to usual eye injections can help diabetic patients with specific eye issues who haven't improved with standard treatments. The goal is to reduce swelling and fluid leakage in the eye to improve vision. Spironolactone has been studied for its effects on heart failure and diabetes, showing some impact on blood glucose levels.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Macular Edema - Volume

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,390 Previous Clinical Trials
2,546,635 Total Patients Enrolled
Mark H Nelson, MD MBAPrincipal InvestigatorWake Forest University Health Sciences
~0 spots leftby Nov 2025
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