DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of Dextenza for the treatment of postoperative pain and inflammation following vitreo-retinal surgery
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This prospective, single-center, open-label, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing vitro-retinal surgery with the treatment of a dexamethasone intracanalicular insert. All patients in the treatment groups will receive a dexamethasone intracanalicular insert. There will be three experimental groups of patients, varying that time of insertion. Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. Ten patients will receive DEXTENZA insert Day 1 post-operatively. Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Pre-surgery Dextenza insert Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops. |
Drug: Dextenza 0.4Mg Ophthalmic Insert
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
|
| Experimental: Group 2 Surgery Day Dextenza insert Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops. |
Drug: Dextenza 0.4Mg Ophthalmic Insert
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
|
| Experimental: Group 3 Post op Day 1 Dextenza insert Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops |
Drug: Dextenza 0.4Mg Ophthalmic Insert
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
|
| Active Comparator: Group 4 Topical steroid Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops. |
Drug: Topical Prednisolone
Standard of care topical drop treatment
|
Outcome Measures
Primary Outcome Measures
- Mean cells as assessed by investigator in anterior chamber of the study eye [Assessed at Day 14]
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
- Mean pain as reported by subject in the study eye: Visual Analog Scale [Assessed at Day 28]
As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
Secondary Outcome Measures
- Mean anterior chamber flare [Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56]
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
- Time to absence of cells [Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56]
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
- Time to absence of pain [Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56]
As measure by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
- Proportion of rescue treatment [Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56]
As measure by Concomitant Medications as rescue therapy
- Assessment of Dextenza ease of insertion [Assessed at Day 1]
As measured by Ease of Use Survey (0=very easy to 10=very hard)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Any adult patient age 18-99 years who is planned to undergo vitreo-retinal surgery (pars plana vitrectomy with or without scleral buckle).
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If both eyes are involved, both eyes would be eligible for the study.
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Willing and able to comply with clinic visits and study related procedures.
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Willing and able to sign the informed consent form.
Exclusion Criteria:
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Patients under age 18.
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Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
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Active infectious ocular or systemic disease.
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Patients with active infectious ocular or extraocular disease.
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Patients actively treated with local or systemic immunosuppression
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Use of the following anti-inflammatory or immunomodulating agents (e.g., cyclosporine) systemically, or in the study eye, for the duration of the study (excluding inhalants). Washout periods for medications prior to surgery are as follows:
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Systemic corticosteroids - 2 weeks (see exception 5c)
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Systemic NSAID over 375 mg per day - 2 weeks
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Periocular/intraocular injection of any corticosteroid solution - 4 weeks (see exception 5b)
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Corticosteroid depot/implant in the study eye - 2 months
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Topical ocular corticosteroid - 7 days
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Topical ocular NSAID - 7 days
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Intraoperatively used intraocular steroid (i.e. intravitreal triamcinolone, that is used to transiently highlight the vitreous and removed during vitrectomy) is permissible in study eye.
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Intraoperatively or perioperatively used systemic steroid for the purpose of general anesthesia (as administered by the treating anesthesiologist) is permissible.
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Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
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Patients with known hypersensitivity to Dexamethasone.
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Patients with uncontrolled glaucoma.
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Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retina Vitreous Surgeons of Central New York, PC | Liverpool | New York | United States | 13088 |
Sponsors and Collaborators
- Patrick R. Oellers, MD
- Ocular Therapeutix, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- The ADHERE Study