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

Phase 2

Terminated

• Conditions: Vitreomacular Traction; Subretinal Edema
• Interventions: Drug: Eplerenone

• Registration Number: NCT04300881
• Lead Sponsor: Wagner Macula & Retina Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-04
• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-09
• Status Verified: 2021-01
• Primary Completion: 2021-01-05
• Study Completion: 2021-01-05
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Eplerenone	Eplerenone

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Central Foveal Thickness (CFT) over time	through study completion, an average of 1 year	Changes as assessed via SD-OCT from the lowest CST measurement in the study, due to disease activity

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in Best Corrected Visual Acuity (BCVA) over time	through study completion, an average of 1 year	Changes as assessed using the visual acuity chart at a starting distance of 4 meters

Trial Locations

Locations (1)

Wagner Macula & Retina Center; 🇺🇸 Norfolk, Virginia, United States