NCT02644694

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 7, 2017

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

December 22, 2015

Last Update Submit

February 6, 2017

Conditions

Vitrectomy

Outcome Measures

Primary Outcomes (2)

  • Concentration of dexamethasone

    Vitreous humor samples will be analyzed for dexamethasone concentrations

    Day 1

  • Concentration of dexamethasone phosphate

    Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations

    Day 1

Study Arms (1)

Dexamethasone Phosphate Ophthalmic Solution

EXPERIMENTAL

Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System

Drug: Dexamethasone Phosphate Ophthalmic Solution

Interventions

Dexamethasone Phosphate Ophthalmic SolutionDRUG

Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System

Dexamethasone Phosphate Ophthalmic Solution

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 85 years
  • Receive, understand, and sign a copy of the written informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Jeffrey Heier, M.D.

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

January 1, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

February 7, 2017

Record last verified: 2016-06

Locations

US(1)