Status:
TERMINATED
Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists)
Lead Sponsor:
Wagner Macula & Retina Center
Collaborating Sponsors:
ThromboGenics
Conditions:
Vitreomacular Traction
Subretinal Edema
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04300881
Start Date
October 4 2019
End Date
January 5 2021
Last Update
January 8 2021
Active Locations (1)
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1
Wagner Macula & Retina Center
Norfolk, Virginia, United States, 23502