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

January 6, 2021 updated by: Wagner Macula & Retina Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Wagner Macula & Retina Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Treatment
Eplerenone
Drug: Eplerenone
Following intravitreal ocriplasmin therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in Central Foveal Thickness (CFT) over time
Time Frame: 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
through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wagner Macula & Retina Center

Collaborators

ThromboGenics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 4, 2019

Primary Completion (ACTUAL)

January 5, 2021

Study Completion (ACTUAL)

January 5, 2021

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

March 4, 2020

First Posted (ACTUAL)

March 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WM562718

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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