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

NCT04300881 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: WM562718
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitreomacular Traction; Subretinal Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes from baseline in Best Corrected Visual Acuity (BCVA) over time

  through study completion, an average of 1 year

Study Arms (2)

Treatment

EXPERIMENTAL

Eplerenone

Drug: Eplerenone

Control

NO INTERVENTION

Interventions

Eplerenone DRUG

Following intravitreal ocriplasmin therapy

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wagner Macula & Retina Center: lead
• ThromboGenics: collaborator

Study Sites (1)

Wagner Macula & Retina Center

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Interventions

Eplerenone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: March 9, 2020
• Study Start: October 4, 2019
• Primary Completion: January 5, 2021
• Study Completion: January 5, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

US (1)