Dextenza in the Post-op Management of Vitreoretinal Surgeries

NCT04371445 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 4-29-2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  day 14 following surgery

Secondary Outcomes (7)

• 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

• 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

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

  day 21 following surgery

• % 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

Study Arms (2)

Intracanalicular dexamethasone insert group

EXPERIMENTAL

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

Drug: Dexamethasone Ophthalmic Insert

Topical steroid drop group

ACTIVE COMPARATOR

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

Interventions

Dexamethasone Ophthalmic Insert DRUG

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.

Also known as: DEXTENZA®

Intracanalicular dexamethasone insert group

Prednisolone Acetate 1% Oph Susp DRUG

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.

Also known as: PRED FORTE®, OMNIPRED®

Topical steroid drop group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 20373127 BACKGROUND

• 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.

  PMID: 25248295 BACKGROUND

• 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.

  PMID: 30367938 BACKGROUND

• 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.

  PMID: 28331295 BACKGROUND

• 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.

  PMID: 16196117 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Calcium Dobesilate; prednisolone acetate; Methylprednisolone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Katherine Talcott, M.D.

  Cole Eye Institute, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Talcott, M.D.

CONTACT

440 988-4040; talcotk@ccf.org

Angela Meador, MHA

CONTACT

216-445-7176; meadora@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Only the readers of the anterior segment OCT will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: June 1, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)