Non-Responsive Diabetic Macular Edema and Spironolactone

NCT ID: NCT04853355

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2022-10-31

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.

Conditions

Diabetic Maculopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spironolactone Treatment

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

Group Type: EXPERIMENTAL

Spironolactone 50 mg

Intervention Type: DRUG

Add Spironolactone 50 mg to previous regimen

Interventions

Spironolactone 50 mg

Add Spironolactone 50 mg to previous regimen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

-

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark H Nelson, MD MBA

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30897068 (View on PubMed)

Other Identifiers

IRB00073697

Identifier Type: -

Identifier Source: org_study_id