Non-Responsive Diabetic Macular Edema and Spironolactone

Diabetic Maculopathy Clinical Trial

Official title:

Non-Responsive Diabetic Macular Edema in Patients With Pachychoroid and Choroidal Hyperpermeability.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04853355
• Other study ID #: IRB00073697
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 2022
• Est. completion date: October 2022

Study information

• Verified date: April 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Diabetic Maculopathy
• Macular Degeneration
• Macular Edema

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eyes with complete reabsorption of intraretinal fluid		1 year
Primary	Macular Edema - Central Subgroup Thickening		1 year
Primary	Macular Edema - Volume	Macular volume	1 year
Primary	Vision, best corrected, logMAR units		1 year
Secondary	Extrafoveal exudation (nCST)		1 year