Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists) (TOTEM)

Wagner Macula & Retina Center

Status and phase

Terminated

Phase 2

Conditions

Vitreomacular Traction

Subretinal Edema

Treatments

Drug: Eplerenone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04300881

WM562718

Details and patient eligibility

About

Evaluate the efficacy of eplerenone as an adjunctive treatment to intravitreal ocriplasmin for subretinal fluid in comparison to a control group of only receiving intravitreal ocriplasmin in patients with symptomatic vitreomacular adhesion.

Enrollment

2 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age > 18 years of age
Symptomatic VMA, VMT, or macular hole
BCVA 20/30 - CF 3' Snellen equivalent
Willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments
JETREA® treatment naïve

Exclusion criteria

Patients who are pregnant, planning to become pregnant, or breastfeeding a child
Uncontrolled ocular hypertension or glaucoma in study (defined as IOP ≥ 25mm Hg or a cup to disc ratio (CDR) > 0.8 despite treatment with anti-glaucoma medication)
Active malignancies within the last 12 months except appropriately treated carcinoma in situ of the crevices, melanoma, and prostate cancers treated with a curative intent
Inability to comply with study or follow-up procedures
Women who may become pregnant or lactating or intend to become pregnant during the study
Known drug allergy to ocriplasmin or eplerenone
Patients with known contraindications Eplerenone as outlined in the package insert