Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced... | NCT04300881

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

NCT04300881

Sponsor

Wagner Macula & Retina Center

Status

Terminated

Last Update Posted

Jan 8, 2021Actual

Enrollment

2Actual

Phase

Phase 2

Conditions

Vitreomacular Traction
Subretinal Edema

Interventions

Eplerenone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment

Expanded Access Info

Start Date

Oct 4, 2019Actual

Primary Completion Date

Jan 5, 2021Actual

Completion Date

Jan 5, 2021Actual

First Submitted Date

Nov 21, 2019

First Submission Date that Met QC Criteria

Mar 4, 2020

First Posted Date

Mar 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2021

Last Update Posted Date

Jan 8, 2021Actual

Name	Class
ThromboGenics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Eplerenone	Drug: Eplerenone
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eplerenone	Drug	Following intravitreal ocriplasmin therapy	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Wagner Macula & Retina Center		Norfolk	Virginia	23502	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000077545	Eplerenone

Ancestor Terms

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256

Browse Leaves

Not provided

Browse Branches

Not provided