NCT04853355

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 2, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

April 20, 2021

Last Update Submit

July 28, 2022

Conditions

Diabetic Maculopathy

Keywords

spironolactoneanti-VEGF injectionsafliberceptEylea

Outcome Measures

Primary Outcomes (4)

  • Proportion of eyes with complete reabsorption of intraretinal fluid

    1 year

  • Macular Edema - Central Subgroup Thickening

    1 year

  • Macular Edema - Volume

    Macular volume

    1 year

  • Vision, best corrected, logMAR units

    1 year

Secondary Outcomes (1)

  • Extrafoveal exudation (nCST)

    1 year

Study Arms (1)

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).

Drug: Spironolactone 50 mg

Interventions

Spironolactone 50 mgDRUG

Add Spironolactone 50 mg to previous regimen

Spironolactone Treatment

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • 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.

    PMID: 30897068BACKGROUND

MeSH Terms

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Mark H Nelson, MD MBA

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, non-randomized, pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 21, 2021

Study Start

July 1, 2022

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

August 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
12 months after completion date
Access Criteria
Contact Principal investigator

Locations

US(1)