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

NCT ID: NCT04300881

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-04

Study Completion Date

2021-01-05

Brief Summary

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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

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Conditions

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Vitreomacular Traction Subretinal Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Eplerenone

Group Type EXPERIMENTAL

Eplerenone

Intervention Type DRUG

Following intravitreal ocriplasmin therapy

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eplerenone

Following intravitreal ocriplasmin therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ThromboGenics

INDUSTRY

Sponsor Role collaborator

Wagner Macula & Retina Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wagner Macula & Retina Center

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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WM562718

Identifier Type: -

Identifier Source: org_study_id

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