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DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery

Primary Purpose

Vitreo-Retinal Surgery

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dextenza 0.4Mg Ophthalmic Insert
Topical Prednisolone
Sponsored by
Patrick R. Oellers, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreo-Retinal Surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any adult patient age 18-99 years who is planned to undergo vitreo-retinal surgery (pars plana vitrectomy with or without scleral buckle).
  • If both eyes are involved, both eyes would be eligible for the study.
  • Willing and able to comply with clinic visits and study related procedures.
  • Willing and able to sign the informed consent form.

Exclusion Criteria:

  • Patients under age 18.
  • Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
  • Active infectious ocular or systemic disease.
  • Patients with active infectious ocular or extraocular disease.
  • Patients actively treated with local or systemic immunosuppression
  • Use of the following anti-inflammatory or immunomodulating agents (e.g., cyclosporine) systemically, or in the study eye, for the duration of the study (excluding inhalants). Washout periods for medications prior to surgery are as follows:
  • Systemic corticosteroids - 2 weeks (see exception 5c)
  • Systemic NSAID over 375 mg per day - 2 weeks
  • Periocular/intraocular injection of any corticosteroid solution - 4 weeks (see exception 5b)
  • Corticosteroid depot/implant in the study eye - 2 months
  • Topical ocular corticosteroid - 7 days
  • Topical ocular NSAID - 7 days
  • Intraoperatively used intraocular steroid (i.e. intravitreal triamcinolone, that is used to transiently highlight the vitreous and removed during vitrectomy) is permissible in study eye.
  • Intraoperatively or perioperatively used systemic steroid for the purpose of general anesthesia (as administered by the treating anesthesiologist) is permissible.
  • Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
  • Patients with known hypersensitivity to Dexamethasone.
  • Patients with uncontrolled glaucoma.
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.

Sites / Locations

  • Retina Vitreous Surgeons of Central New York, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1 Pre-surgery Dextenza insert

Group 2 Surgery Day Dextenza insert

Group 3 Post op Day 1 Dextenza insert

Group 4 Topical steroid

Arm Description

Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.

Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.

Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops

Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.

Outcomes

Primary Outcome Measures

Mean cells as assessed by investigator in anterior chamber of the study eye
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Mean pain as reported by subject in the study eye: Visual Analog Scale
As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)

Secondary Outcome Measures

Mean anterior chamber flare
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Time to absence of cells
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Time to absence of pain
As measure by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
Proportion of rescue treatment
As measure by Concomitant Medications as rescue therapy
Assessment of Dextenza ease of insertion
As measured by Ease of Use Survey (0=very easy to 10=very hard)

Full Information

First Posted
June 24, 2020
Last Updated
June 14, 2023
Sponsor
Patrick R. Oellers, MD
Collaborators
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04462523
Brief Title
DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery
Official Title
Open-label, Single -Center, Prospective Study on the Efficacy and Safety of Intracanalicular Dexamethasone Insert 0.4mg (Dextenza) in the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery - The ADHERE Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick R. Oellers, MD
Collaborators
Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate efficacy and safety of Dextenza for the treatment of postoperative pain and inflammation following vitreo-retinal surgery
Detailed Description
This prospective, single-center, open-label, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing vitro-retinal surgery with the treatment of a dexamethasone intracanalicular insert. All patients in the treatment groups will receive a dexamethasone intracanalicular insert. There will be three experimental groups of patients, varying that time of insertion. Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. Ten patients will receive DEXTENZA insert Day 1 post-operatively. Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreo-Retinal Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Masked Sub-investigators to exam subjects at each visit after clinical evaluation for cell and/or flare.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Pre-surgery Dextenza insert
Arm Type
Experimental
Arm Description
Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
Arm Title
Group 2 Surgery Day Dextenza insert
Arm Type
Experimental
Arm Description
Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
Arm Title
Group 3 Post op Day 1 Dextenza insert
Arm Type
Experimental
Arm Description
Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops
Arm Title
Group 4 Topical steroid
Arm Type
Active Comparator
Arm Description
Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
Intervention Type
Drug
Intervention Name(s)
Dextenza 0.4Mg Ophthalmic Insert
Intervention Description
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Intervention Type
Drug
Intervention Name(s)
Topical Prednisolone
Intervention Description
Standard of care topical drop treatment
Primary Outcome Measure Information:
Title
Mean cells as assessed by investigator in anterior chamber of the study eye
Description
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Time Frame
Assessed at Day 14
Title
Mean pain as reported by subject in the study eye: Visual Analog Scale
Description
As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
Time Frame
Assessed at Day 28
Secondary Outcome Measure Information:
Title
Mean anterior chamber flare
Description
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Time Frame
Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Title
Time to absence of cells
Description
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Time Frame
Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Title
Time to absence of pain
Description
As measure by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
Time Frame
Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Title
Proportion of rescue treatment
Description
As measure by Concomitant Medications as rescue therapy
Time Frame
Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Title
Assessment of Dextenza ease of insertion
Description
As measured by Ease of Use Survey (0=very easy to 10=very hard)
Time Frame
Assessed at Day 1

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any adult patient age 18-99 years who is planned to undergo vitreo-retinal surgery (pars plana vitrectomy with or without scleral buckle). If both eyes are involved, both eyes would be eligible for the study. Willing and able to comply with clinic visits and study related procedures. Willing and able to sign the informed consent form. Exclusion Criteria: Patients under age 18. Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test). Active infectious ocular or systemic disease. Patients with active infectious ocular or extraocular disease. Patients actively treated with local or systemic immunosuppression Use of the following anti-inflammatory or immunomodulating agents (e.g., cyclosporine) systemically, or in the study eye, for the duration of the study (excluding inhalants). Washout periods for medications prior to surgery are as follows: Systemic corticosteroids - 2 weeks (see exception 5c) Systemic NSAID over 375 mg per day - 2 weeks Periocular/intraocular injection of any corticosteroid solution - 4 weeks (see exception 5b) Corticosteroid depot/implant in the study eye - 2 months Topical ocular corticosteroid - 7 days Topical ocular NSAID - 7 days Intraoperatively used intraocular steroid (i.e. intravitreal triamcinolone, that is used to transiently highlight the vitreous and removed during vitrectomy) is permissible in study eye. Intraoperatively or perioperatively used systemic steroid for the purpose of general anesthesia (as administered by the treating anesthesiologist) is permissible. Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction. Patients with known hypersensitivity to Dexamethasone. Patients with uncontrolled glaucoma. Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
Facility Information:
Facility Name
Retina Vitreous Surgeons of Central New York, PC
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States

12. IPD Sharing Statement

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DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery

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