Non-Responsive Diabetic Macular Edema and Spironolactone

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04853355
Collaborator
(none)
0
1
1
3
0

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Spironolactone 50 mg
Phase 4

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

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, non-randomized, pilot studyProspective, non-randomized, pilot study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non-Responsive Diabetic Macular Edema in Patients With Pachychoroid and Choroidal Hyperpermeability.
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Spironolactone Treatment

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

Drug: Spironolactone 50 mg
Add Spironolactone 50 mg to previous regimen

Outcome Measures

Primary Outcome Measures

  1. Proportion of eyes with complete reabsorption of intraretinal fluid [1 year]

  2. Macular Edema - Central Subgroup Thickening [1 year]

  3. Macular Edema - Volume [1 year]

    Macular volume

  4. Vision, best corrected, logMAR units [1 year]

Secondary Outcome Measures

  1. Extrafoveal exudation (nCST) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion:
  1. 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).

  2. 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.

  3. Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study (ETDRS).

  4. 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).

Exclusion:
  1. Exudative maculopathies due to myopic choroidal degeneration, histoplasmosis, trauma, and specifically, the presence of angioid streaks.

  2. Myocardial infarction or cerebrovascular accident within the last 6 weeks

  3. Previous vitrectomy

  4. Hypokalemia

  5. Optic neuropathy

  6. Traction maculopathies

  7. Allergies to fluorescein and indocyanine, dilating agents, spironolactone, triamcinolone or anti-VEGF medications

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Mark H Nelson, MD MBA, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT04853355
Other Study ID Numbers:
  • IRB00073697
First Posted:
Apr 21, 2021
Last Update Posted:
Aug 2, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Wake Forest University Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022