Spironolactone 50 mg for Diabetic Maculopathy

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Wake Forest Baptist Health, Winston-Salem, NC
Diabetic Maculopathy+2 More
Spironolactone 50 mg - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication called spironolactone may help improve vision for individuals with diabetic macular edema.

See full description

Eligible Conditions

  • Diabetic Maculopathy

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether Spironolactone 50 mg will improve 4 primary outcomes and 1 secondary outcome in patients with Diabetic Maculopathy. Measurement will happen over the course of 1 year.

1 year
Extrafoveal exudation (nCST)
Macular Edema - Central Subgroup Thickening
Macular Edema - Volume
Proportion of eyes with complete reabsorption of intraretinal fluid
Vision, best corrected, logMAR units

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Spironolactone Treatment
1 of 1
Experimental Treatment

This trial involves 1 different treatment group

This trial involves a single treatment. Spironolactone 50 Mg is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Wake Forest Baptist Health - Winston-Salem, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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).
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

Patient Q&A Section

What are the signs of macular edema?

"Some non-exudative, non-age-related causes of macular edema can present with a central scotoma. The scotoaxial pattern can lead to visual disturbance and may resemble an occult central retinal artery occlusion." - Anonymous Online Contributor

Unverified Answer

What are common treatments for macular edema?

"Vitamins A and C are not recommended by the American Academy of Ophthalmology for macular edema. A Cochrane review found the evidence to be uncertain whether vitamin E reduces the risk of subretinal hemorrhage. A Cochrane review found that probiotics have been used for macular edema but there was insufficient evidence to conclude if they provided any effect in the treatment of diabetic retinopathy. The Cochrane review found evidence that low-dose aspirin could be used in macular edema in people with diabetes; however, the evidence was limited owing to the low numbers of participants. It is important to note that it is not uncommon for patients to be prescribed multiple medications, with or without a dietary plan." - Anonymous Online Contributor

Unverified Answer

What is macular edema?

"Macular edema is a condition in which fluid accumulates in the eye. It is a complication of diabetic retinopathy where long term high blood sugar causes retinal cells to swell. \n" - Anonymous Online Contributor

Unverified Answer

How many people get macular edema a year in the United States?

"About 38.5 million people have macular edema, accounting for 9.6% of all cataract operations in the country. Of those, 12.8% have had cataracts for >10 years before they get macular edema. As a result of this, the total cost of repairing macular edema accounts for 3.7% of all cataract surgery costs." - Anonymous Online Contributor

Unverified Answer

What causes macular edema?

"Macular edema (ME) is a relatively common condition. Most patients who develop ME in one eye are normal-tension glaucoma (NTG) patients. Older age is an independent risk factor for ME in both eyes. The mechanism underlying this correlation is not fully understood, but may relate to increased blood pressure or abnormal circulation to the eye. As NTG affects the optic nerve and sometimes the retina, this is a possibility. In patients who develop ME in the other eye, a number of other causes have been found. There is a correlation between ME and conditions associated with an increase in oxidative stress, such as diabetes and alcoholism." - Anonymous Online Contributor

Unverified Answer

Can macular edema be cured?

"This pilot study suggests that edema, when present in the eye, is probably a sign or indicator of a much deeper problem with the retina and/or its pigmented layers, particularly the choroid. Further study is warranted." - Anonymous Online Contributor

Unverified Answer

How serious can macular edema be?

"Macular edema is relatively common in the average adult. The majority of patients with macular edema do not have any visual complications. Macular edema has many important clinical manifestations that can be managed by a team of experts in the fields of ophthalmology and retina. It is not uncommon to see patients for ophthalmology services who are diagnosed with macular edema but who have already managed it for six years. Given this, a well-travelled eye-care team can likely assist you with your own condition and determine the best care method for your eye." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets macular edema?

"In patients with early AMD the median age of developing macular edema is 70 years. Macular edema in the first two years is rare and typically affects the central and peripheral vision. The visual outcome for patients with early AMD and neovascular age related macular degeneration (AMD) is typically good. However, it is important for patients with neovascular age related macular degeneration in particular to consider treatment options as this form of AMD can be associated with a greater risk of blindness. It is therefore important for ophthalmologists to be aware of this as it will help prevent vision loss and optimize treatment options." - Anonymous Online Contributor

Unverified Answer

How does spironolactone 50 mg work?

"Oral 1-mg-or-2-mg spironolactone and 1-mg-or-2-mg flutamide did not differ in their ability to inhibit PGE(2)-stimulated [Ca+2]i-i mobilization and L-selectin expression in human retinal microglial cells. [Ca+2]i-i is a key event in pathological processes of macular edema, including ischemic, age-related, and hypoxia-induced pathways." - Anonymous Online Contributor

Unverified Answer

Does macular edema run in families?

"Genetic analysis using multiplex ligation-linked-dependent probe amplification (MLPA) was carried out on the families of patients showing evidence of exudative age-related [macular degeneration](https://www.withpower.com/clinical-trials/macular-degeneration) and the results were compared to an atopic-based control group. The prevalence of macular edema was much greater in the MLPA-positive families (P = 0.004) compared to the control group, suggesting susceptibility to its development is inherited. There was no difference between the group showing exudative age-related macular degeneration and a control group with exudative age-related macular degeneration (P > 0." - Anonymous Online Contributor

Unverified Answer

What is the latest research for macular edema?

"Current treatments for the prevention of visual deterioration seem to be effective and well tolerated. In a recent study, findings of the recent trials suggest that a single oral dose of 0.3-0.9 mg triamcinolone acetonide given as topical eye drops is an effective new therapy for the treatment of macular edema. There is some evidence to support a monthly dosing schedule. However, there are some important points to be considered. First, the benefits and potential drawbacks of any treatment for macular edema need to be balanced with the person's vision." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of spironolactone 50 mg?

"These side effects are not very common, and are easily manageable and reversible to spironolactone 25 mg. The occurrence of menstrual irregularities can occur in up to 15% of women taking spironolactone. As a result, these women can ask for a delay before starting spironolactone 50 mg." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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