Status:
WITHDRAWN
Non-Responsive Diabetic Macular Edema and Spironolactone
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Diabetic Maculopathy
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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...
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 h...
Eligibility Criteria
Inclusion
- Inclusion:
- 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).
- Exclusion:
- 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
- \-
Exclusion
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04853355
Start Date
July 1 2022
End Date
October 1 2022
Last Update
August 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157