Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04501367
Other study ID # Kovacheye
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 27, 2021
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source Kovach Eye Institute
Contact Saad Ahmad, MD
Phone 6308339361
Email ifixretinas@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi 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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study: - 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 Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: - 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

Study Design


Intervention

Drug:
Dexamethasone Intracanalicular Insert, 0.4 mg
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
Dexamethasone Intracanalicular Insert, 0.4 mg
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
Prednisone acetate 1%
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery

Locations

Country Name City State
United States Kovach Eye Institute Elmhurst Illinois

Sponsors (1)

Lead Sponsor Collaborator
Kovach Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in retina edema As measured by Optical Coherence Tomography (OCT) assessed on day 30 and day 60
Secondary Mean change in Inflammation ( Cell and Flare) As measured by SUN (Standardization of 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 as assessed on days 1, 7, 30, 60
Secondary Mean change in pain scores as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible as assessed on days 1, 7, 30, 60
Secondary Mean Change in Best- Corrected Visual Acuity (BCVA) as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart from baseline at days 1, 7, 30, 60
Secondary Physician ease of Dextenza insertion measured by a 0-10 scale as assessed on day of surgery
See also
  Status Clinical Trial Phase
Terminated NCT04409808 - IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device. N/A
Active, not recruiting NCT04566237 - Objective Measurements of the Opacification of the Lens After Vitrectomy N/A
Completed NCT00532415 - Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy Phase 3
Completed NCT04076072 - Beveled-Tip Versus(vs) Standard-Tip Vitrectomy Probe N/A
Not yet recruiting NCT03633266 - Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy N/A
Completed NCT00927628 - Macular Hole Reopening N/A
Not yet recruiting NCT03637283 - Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage N/A
Completed NCT01255293 - Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments N/A
Terminated NCT01023009 - Postoperative Evolution After Small Gauge Vitrectomy Without Eye Occlusion
Completed NCT00737022 - Macular Appearance After Diabetic Vitrectomy N/A
Completed NCT03902795 - Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy
Completed NCT02644694 - PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy Phase 1
Completed NCT01319318 - Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy N/A
Not yet recruiting NCT04346095 - Oral Sedation in Vitreoretinal Surgery Phase 4
Completed NCT01159665 - The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV) Phase 2
Completed NCT00685490 - Vitrectomy for Branch Retinal Vein Occlusion N/A
Completed NCT05446948 - Observation of the Efficacy of Different Vitrectomy Systems to Treat Proliferative Diabetic Retinopathy N/A
Completed NCT05710458 - Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter N/A
Terminated NCT02995746 - Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane N/A
Completed NCT03701542 - The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.