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

Vitreomacular Traction Clinical Trial

— TOTEM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04300881
• Other study ID #: WM562718
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Subretinal Edema
• Vitreomacular Traction

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