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

• Status: Terminated
• Trial end date: 2021-01-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wagner Macula & Retina Center
• Collaborator: ThromboGenics
• Treatments: Eplerenone; Mineralocorticoid Receptor Antagonists; Mineralocorticoids

Criteria

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