Dextenza in the Post-op Management of Vitreoretinal Surgeries

Sponsor

The Cleveland Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04371445

Collaborator

Ocular Therapeutix, Inc. (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitreoretinal Surgery Ocular Inflammation Post-operative Pain Post-Operative Inflammation	Drug: Dexamethasone Ophthalmic Insert Drug: Prednisolone Acetate 1% Oph Susp	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intracanalicular dexamethasone insert group This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery.	Drug: Dexamethasone Ophthalmic Insert 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. Other Names: DEXTENZA®
Active Comparator: Topical steroid drop group 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.	Drug: Prednisolone Acetate 1% Oph Susp 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. Other Names: PRED FORTE®, OMNIPRED®

Arm

Intervention/Treatment

Experimental: Intracanalicular dexamethasone insert group

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

Drug: Dexamethasone Ophthalmic Insert

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.

Other Names:

DEXTENZA®

Active Comparator: Topical steroid drop group

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.

Drug: Prednisolone Acetate 1% Oph Susp

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.

Other Names:

PRED FORTE®, OMNIPRED®

Outcome Measures

Primary Outcome Measures

To assess control of inflammation following the vitreoretinal surgical procedure. [day 14 following surgery]
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. [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. [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. [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. [day 21 following surgery]
% of patients receiving rescue treatment. [days 1, 7, 14, and 21 following surgery]
% of patients with postoperative management via telephone or electronic messaging [day 21 following surgery]
The incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between arms. [day 21 following surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.