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

• Sponsor: Wagner Macula & Retina Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04300881
• Collaborator: ThromboGenics (Industry)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Oct 4, 2019
• Actual Primary Completion Date: Jan 5, 2021
• Actual Study Completion Date: Jan 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Eplerenone	Drug: Eplerenone; Following intravitreal ocriplasmin therapy
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Changes from baseline in Central Foveal Thickness (CFT) over time [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 [through study completion, an average of 1 year]

   Changes as assessed using the visual acuity chart at a starting distance of 4 meters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wagner Macula & Retina Center	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

• Wagner Macula & Retina Center
• ThromboGenics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wagner Macula & Retina Center
• ClinicalTrials.gov Identifier: NCT04300881
• Other Study ID Numbers: WM562718
• First Posted: Mar 9, 2020
• Last Update Posted: Jan 8, 2021
• Last Verified: Jan 1, 2021

• 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: Eplerenone

Study Results

No Results Posted as of Jan 8, 2021