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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04300881

Acronym

TOTEM

Enrollment

Registered

2020-03-09

Start date

2019-10-04

Completion date

2021-01-05

Last updated

2021-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subretinal Edema, Vitreomacular Traction

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.

Interventions

DRUGEplerenone

Following intravitreal ocriplasmin therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026