NCT04464629

Brief Summary

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.

Trial Health

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Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

July 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

July 14, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

July 6, 2020

Last Update Submit

August 14, 2023

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (2)

  • Mean change in pain score

    Average change in pain based on whats reported on the Ocular Pain Assessment

    30 Days

  • Post-op pain scores

    Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.

    30 Days

Secondary Outcomes (4)

  • Mean change in anterior chamber cell and flare score

    30 days

  • Cystoid Macular Edema

    30 days

  • Best Corrected Visual Acuity

    90 days

  • Physician Ease of Dextenza insertion

    Day 1

Study Arms (2)

Intracanalicular Sustained Release Dexamethasone, 0.4 mg

EXPERIMENTAL

Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery.

Drug: Dextenza

topical prednisolone acetate 1%.

ACTIVE COMPARATOR
Drug: Prednisolone Acetate

Interventions

DextenzaDRUG

Intracanalicular sustained release dexamethasone insert 0.4 mg

Intracanalicular Sustained Release Dexamethasone, 0.4 mg
Prednisolone AcetateDRUG

Topical Prednisolone acetate 1% ophthalmic suspension

topical prednisolone acetate 1%.

Eligibility Criteria

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

You may qualify if:

  • Pseudophakic
  • Retinal Detachment
  • Age 18 years and older
  • Scheduled for gas bubble repair and laser surgery following retinal detachment
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

You may not qualify if:

  • Patients under the age of 18.
  • Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
  • Active infectious systemic disease
  • Active infectious ocular or extraocular disease
  • Obstructed nasolacrimal duct in the study eye(s)
  • Hypersensitivity to dexamethasone
  • Patients being treated with immunomodulating agents in the study eye(s)
  • Patients being treated with immunosuppressants and/or oral steroids
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

MeSH Terms

Conditions

Retinal Detachment

Interventions

Calcium Dobesilateprednisolone acetate

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Neil Finnen, MD

    Midwest Medical Advisors, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 9, 2020

Study Start

July 14, 2020

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)