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Dextenza in the Post-op Management of Vitreoretinal Surgeries

Primary Purpose

Vitreoretinal Surgery, Ocular Inflammation, Post-operative Pain

Status

Enrolling by invitation

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone Ophthalmic Insert

Prednisolone Acetate 1% Oph Susp

About this trial

This is an interventional prevention trial for Vitreoretinal Surgery focused on measuring dexamethasone insert, Ocular Inflammation, Post-Operative Inflammation, Post-operative Pain

Eligibility Criteria

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

Inclusion Criteria:

Men and women >18 years old
Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Exclusion Criteria:

Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system
History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye
Structural lid abnormalities such as ectropion or entropion in surgical eye
Ongoing use of systemic narcotic pain relievers
Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline
Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline
Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes
Other ocular surgeries or procedures during the study period and/or 6 months prior
Intraoperative complications
Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled.
Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.
Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery.
Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.
Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure
Are pregnant or nursing/lactating
Participation as a subject in any clinical study within the 30 days prior to randomization.
Surgeries using 20 gauge or 23 gauge instruments.

Sites / Locations

Cole Eye Institute, Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intracanalicular dexamethasone insert group

Topical steroid drop group

Arm Description

This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery.

This arm will receive the prescription for daily prednisolone acetate 1% eye drops 4 times a day for the first week following the procedure, starting on the day of surgery.

Outcomes

Primary Outcome Measures

To assess control of inflammation following the vitreoretinal surgical procedure.

Percentage of patients with Inflammation following surgery as assessed from 0-4+ cell and flare based on the Standardization of Uveitis Nomenclature [SUN] Working Group grading scheme at day 14

Secondary Outcome Measures

The patient reporting of pain following surgery using visual analog pain scale at days 1, 3, 7, 14, and 21 following surgery.

Pain following surgery will be measured using a scale from 0 to10 (0 = no pain, 10 = severe pain that prevents performing activities of daily living). Higher scores mean a worse outcome.

Inflammation assessed on Anterior Segment OCT by masked grading at days 1, 7, 14, and 21 following surgery.

Anterior segment will be assessed using a continuous variable (cells/mm3).

Mean change in Best Corrected Visual Acuity (BCVA) from baseline to day 21 following surgery.

BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method.

% of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading.

% of patients receiving rescue treatment.

% of patients with postoperative management via telephone or electronic messaging

The incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between arms.

Full Information

NCT ID

NCT04371445

First Posted

April 29, 2020

Last Updated

January 26, 2023

Sponsor

The Cleveland Clinic

Collaborators

Ocular Therapeutix, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04371445

Brief Title

Dextenza in the Post-op Management of Vitreoretinal Surgeries

Official Title

Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Cleveland Clinic

Collaborators

Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Detailed Description

Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days. The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitreoretinal Surgery, Ocular Inflammation, Post-operative Pain, Post-Operative Inflammation

Keywords

dexamethasone insert, Ocular Inflammation, Post-Operative Inflammation, Post-operative Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Masking Description

Only the readers of the anterior segment OCT will be masked.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intracanalicular dexamethasone insert group

Arm Type

Experimental

Arm Description

This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery.

Arm Title

Topical steroid drop group

Arm Type

Active Comparator

Arm Description

This arm will receive the prescription for daily prednisolone acetate 1% eye drops 4 times a day for the first week following the procedure, starting on the day of surgery.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone Ophthalmic Insert

Other Intervention Name(s)

DEXTENZA®

Intervention Description

DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care including topical antibiotics.

Intervention Type

Drug

Intervention Name(s)

Prednisolone Acetate 1% Oph Susp

Other Intervention Name(s)

PRED FORTE®, OMNIPRED®

Intervention Description

Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care including topical antibiotics.

Primary Outcome Measure Information:

Title

To assess control of inflammation following the vitreoretinal surgical procedure.

Description

Percentage of patients with Inflammation following surgery as assessed from 0-4+ cell and flare based on the Standardization of Uveitis Nomenclature [SUN] Working Group grading scheme at day 14

Time Frame

day 14 following surgery

Secondary Outcome Measure Information:

Title

The patient reporting of pain following surgery using visual analog pain scale at days 1, 3, 7, 14, and 21 following surgery.

Description

Pain following surgery will be measured using a scale from 0 to10 (0 = no pain, 10 = severe pain that prevents performing activities of daily living). Higher scores mean a worse outcome.

Time Frame

days 1, 3, 7, 14, and 21 following surgery

Title

Inflammation assessed on Anterior Segment OCT by masked grading at days 1, 7, 14, and 21 following surgery.

Description

Anterior segment will be assessed using a continuous variable (cells/mm3).

Time Frame

days 1, 7, 14, and 21 following surgery

Title

Mean change in Best Corrected Visual Acuity (BCVA) from baseline to day 21 following surgery.

Description

BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method.

Time Frame

day 21 following surgery

Title

% of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading.

Time Frame

day 21 following surgery

Title

% of patients receiving rescue treatment.

Time Frame

days 1, 7, 14, and 21 following surgery

Title

% of patients with postoperative management via telephone or electronic messaging

Time Frame

day 21 following surgery

Title

The incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between arms.

Time Frame

day 21 following surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women >18 years old Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction. Exclusion Criteria: Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye Structural lid abnormalities such as ectropion or entropion in surgical eye Ongoing use of systemic narcotic pain relievers Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes Other ocular surgeries or procedures during the study period and/or 6 months prior Intraoperative complications Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled. Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication. Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery. Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively. Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure Are pregnant or nursing/lactating Participation as a subject in any clinical study within the 30 days prior to randomization. Surgeries using 20 gauge or 23 gauge instruments.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katherine Talcott, M.D.

Organizational Affiliation

Cole Eye Institute, Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cole Eye Institute, Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is not a plan to make IPD available.

Citations:

PubMed Identifier

20373127

Citation

Hermann MM, Ustundag C, Diestelhorst M. Electronic compliance monitoring of topical treatment after ophthalmic surgery. Int Ophthalmol. 2010 Aug;30(4):385-90. doi: 10.1007/s10792-010-9362-3. Epub 2010 Apr 7.

Results Reference

background

PubMed Identifier

25248295

Citation

An JA, Kasner O, Samek DA, Levesque V. Evaluation of eyedrop administration by inexperienced patients after cataract surgery. J Cataract Refract Surg. 2014 Nov;40(11):1857-61. doi: 10.1016/j.jcrs.2014.02.037. Epub 2014 Sep 22.

Results Reference

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PubMed Identifier

30367938

Citation

Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24. Erratum In: J Cataract Refract Surg. 2019 Jun;45(6):895.

Results Reference

background

PubMed Identifier

28331295

Citation

Gira JP, Sampson R, Silverstein SM, Walters TR, Metzinger JL, Talamo JH. Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza): results of a qualitative survey. Patient Prefer Adherence. 2017 Mar 8;11:487-494. doi: 10.2147/PPA.S126283. eCollection 2017.

Results Reference

background

PubMed Identifier

16196117

Citation

Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.

Results Reference

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Dextenza in the Post-op Management of Vitreoretinal Surgeries

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