Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

NCT04501367 | Unknown Phase 4 FDA Drug

• 1 other identifier: Kovacheye
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel

Conditions

Vitrectomy; Macular Pucker; Retinal Edema

Outcome Measures

Primary Outcomes (1)

• Mean change in retina edema

  As measured by Optical Coherence Tomography (OCT)

  assessed on day 30 and day 60

Secondary Outcomes (4)

• Mean change in Inflammation ( Cell and Flare)

  as assessed on days 1, 7, 30, 60

• Mean change in pain scores

  as assessed on days 1, 7, 30, 60

• Mean Change in Best- Corrected Visual Acuity (BCVA)

  from baseline at days 1, 7, 30, 60

• Physician ease of Dextenza insertion

  as assessed on day of surgery

Study Arms (3)

DEXTENZA Group

EXPERIMENTAL

Patients undergoing vitrectomy with internal limiting membrane peel

Drug: Dexamethasone Intracanalicular Insert, 0.4 mg

Second DEXTENZA Group

EXPERIMENTAL

Patients undergoing vitrectomy with internal limiting membrane peel

Drug: Dexamethasone Intracanalicular Insert, 0.4 mg

Topical Prednisolone Acetate 1% Group

EXPERIMENTAL

Patients undergoing vitrectomy with internal limiting membrane peel

Drug: Prednisone acetate 1%

Interventions

Dexamethasone Intracanalicular Insert, 0.4 mg DRUG

To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery

DEXTENZA Group

Prednisone acetate 1% DRUG

To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery

Topical Prednisolone Acetate 1% Group

Eligibility Criteria

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

You may qualify if:

• Symptomatic macular pucker with retinal edema
• Age 18 years and older
• Scheduled vitrectomy and internal limiting membrane peel
• 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
• 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)
• Patient 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

• Kovach Eye Institute: lead

Study Sites (1)

Kovach Eye Institute

Elmhurst, Illinois, 60126, United States

RECRUITING

MeSH Terms

Conditions

Epiretinal Membrane; Papilledema

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Saad Ahmad, MD

  Kovach Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saad Ahmad, MD

CONTACT

6308339361; ifixretinas@gmail.com

Jamie White, Bachelors

CONTACT

6308339621; jamie.white@kovacheye.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In patients who undergo vitrectomy with internal limiting membrane peel surgery , subjects will be randomized to three groups and be followed for a period of two months. One group will be selected to receive one DEXTENZA (in the lower canaliculus), the second group will receive two DEXTENZA (upper and lower canaliculi) and the third group will receive prednisolone acetate 1% (control eye) . All groups will receive a subconjunctival dexamethasone injection at the time of surgery.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 6, 2020
• Study Start: April 27, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)