Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery

NCT04521140 | Completed Phase 4 FDA Drug

• 1 other identifier: AVC-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.

Conditions

Corneal Edema; Corneal Defect; Corneal Transplant; Penetrating KeratoPlasty; Anterior Chamber Inflammation; Ocular Pain; Intraocular Pressure

Outcome Measures

Primary Outcomes (2)

• Mean change in pain score

  as measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible

  Assessed on Day 1,7 and 30

• Mean change in inflammation (Cell and Flare) scores

  as measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1

  Assessed on Day 1,7 and 30

Secondary Outcomes (4)

• Mean change in duration to corneal re-epithelization

  Assessed on Day 1 and 7

• Mean change in size of epithelial defect

  Assessed on Day 1 and 7

• Impact on the practice/medical team of decreasing the drop burden

  Assessed on day 30

• Mean change in duration to clearing of corneal edema

  Assessed on Day 30, 60 and 90

Study Arms (6)

PKP with Dextenza (study)

EXPERIMENTAL

Patients undergoing PKP will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp

PKP without Dextenza (Controlled)

OTHER

Patients undergoing PKP will receive: topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Drug: Prednisolone Acetate 1% Oph Susp

DSEK with Dextenza (study)

EXPERIMENTAL

Patients undergoing DSEK will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp

DSEK without Dextenza (Controlled)

OTHER

Patients undergoing DSEK will receive: topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Drug: Prednisolone Acetate 1% Oph Susp

DMEK with Dextenza (study)

EXPERIMENTAL

will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp

DMEK without Dextenza (Controlled)

OTHER

Patients undergoing DMEK will receive: topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Drug: Prednisolone Acetate 1% Oph Susp

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.

Also known as: Dexamethasone Ophthalmic Insert

DMEK with Dextenza (study); DSEK with Dextenza (study); PKP with Dextenza (study)

Prednisolone Acetate 1% Oph Susp DRUG

Prednisolone Acetate 1% is a corticosteroid used as a topical drop after corneal transplant to decrease inflammation and prevent graft rejection

Also known as: Omnipred, Pred Forte

DMEK with Dextenza (study); DMEK without Dextenza (Controlled); DSEK with Dextenza (study); DSEK without Dextenza (Controlled); PKP with Dextenza (study); PKP without Dextenza (Controlled)

Eligibility Criteria

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

You may qualify if:

• Age 18 years and older
• Scheduled corneal transplant surgery: PKP, DSEK, DMEK
• 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
• Presence of punctal plug in the study eye
• Obstructed nasolacrimal duct in the study eye(s)
• Hypersensitivity to dexamethasone or prednisolone eye drops
• 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

Sponsors & Collaborators

• Nicole Fram M.D.: lead

Study Sites (1)

Advanced Vision Care

Los Angeles, California, 90067, United States

Location

Related Publications (3)

• Anshu A, Price MO, Price FW Jr. Risk of corneal transplant rejection significantly reduced with Descemet's membrane endothelial keratoplasty. Ophthalmology. 2012 Mar;119(3):536-40. doi: 10.1016/j.ophtha.2011.09.019. Epub 2012 Jan 3.

  PMID: 22218143 BACKGROUND

• Price MO, Scanameo A, Feng MT, Price FW Jr. Descemet's Membrane Endothelial Keratoplasty: Risk of Immunologic Rejection Episodes after Discontinuing Topical Corticosteroids. Ophthalmology. 2016 Jun;123(6):1232-6. doi: 10.1016/j.ophtha.2016.02.001. Epub 2016 Mar 13.

  PMID: 26983976 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

MeSH Terms

Conditions

Corneal Edema; Eye Pain

Interventions

Calcium Dobesilate; prednisolone acetate; Methylprednisolone

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

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

• Nicole Fram, MD

  Advanced Vision Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In patient who undergo corneal transplant (PKP,DSEK,DMEK), subjects will be randomized to 6 arms and be followed for a period of 3 months. First arm will Receive Dextenza with PKP, Second arm will receive Prednisolone Acetate 1% with PKP, Third arm will Receive Dextenza with DSEK, Forth arm will receive Prednisolone Acetate 1% with DSEK Fifth arm will Receive Dextenza with DMEK, Sixth arm will receive Prednisolone Acetate 1% with DMEK

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: October 16, 2020
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)