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

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ClinicalTrials.gov Identifier: NCT04300881
Recruitment Status : Terminated (Enrollment)
First Posted : March 9, 2020
Last Update Posted : January 8, 2021
Sponsor:
Collaborator:
ThromboGenics
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vitreomacular Traction Subretinal Edema Drug: Eplerenone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists): The TOTEM Study
Actual Study Start Date : October 4, 2019
Actual Primary Completion Date : January 5, 2021
Actual Study Completion Date : January 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Eplerenone
Drug: Eplerenone
Following intravitreal ocriplasmin therapy

No Intervention: Control



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300881


Locations
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United States, Virginia
Wagner Macula & Retina Center
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Wagner Macula & Retina Center
ThromboGenics
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Responsible Party: Wagner Macula & Retina Center
ClinicalTrials.gov Identifier: NCT04300881    
Other Study ID Numbers: WM562718
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021

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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
Additional relevant MeSH terms:
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Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents