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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04300881
Other study ID # WM562718
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 4, 2019
Est. completion date January 5, 2021

Study information

Verified date January 2021
Source Wagner Macula & Retina Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date January 5, 2021
Est. primary completion date January 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Eplerenone
Following intravitreal ocriplasmin therapy

Locations

Country Name City State
United States Wagner Macula & Retina Center Norfolk Virginia

Sponsors (2)

Lead Sponsor Collaborator
Wagner Macula & Retina Center ThromboGenics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline in Central Foveal Thickness (CFT) over time Changes as assessed via SD-OCT from the lowest CST measurement in the study, due to disease activity through study completion, an average of 1 year
Secondary Changes from baseline in Best Corrected Visual Acuity (BCVA) over time Changes as assessed using the visual acuity chart at a starting distance of 4 meters through study completion, an average of 1 year
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