Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Miner⦠(NCT04300881) | Clinical Trial Compass
TerminatedPhase 2
Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists)
Stopped: Enrollment
United States2 participantsStarted 2019-10-04
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* JETREAĀ® treatment naĆÆve
Exclusion Criteria:
* Patients who are pregnant, planning to become pregnant, or breastfeeding a child
* Uncontrolled ocular hypertension or glaucoma in study (defined as IOP ā„ 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
What they're measuring
1
Changes from baseline in Central Foveal Thickness (CFT) over time
Timeframe: through study completion, an average of 1 year