Vitreomacular Traction Clinical Trial
— TOTEMOfficial title:
Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists): The TOTEM Study
Verified date | January 2021 |
Source | Wagner Macula & Retina Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wagner Macula & Retina Center | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Wagner Macula & Retina Center | ThromboGenics |
United States,
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 |
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