DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery

Sponsor
Patrick R. Oellers, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT04462523
Collaborator
Ocular Therapeutix, Inc. (Industry)
40
Enrollment
1
Location
4
Arms
11.9
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Drug: Dextenza 0.4Mg Ophthalmic Insert
  • Drug: Topical Prednisolone
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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Masked Sub-investigators to exam subjects at each visit after clinical evaluation for cell and/or flare.
Primary Purpose:
Treatment
Official Title:
Open-label, Single -Center, Prospective Study on the Efficacy and Safety of Intracanalicular Dexamethasone Insert 0.4mg (Dextenza) in the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery - The ADHERE Study
Actual Study Start Date :
Jan 3, 2020
Anticipated Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

ArmIntervention/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

  1. 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+)

  2. 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

  1. 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+)

  2. 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+)

  3. 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)

  4. 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

  5. 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

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

  • If both eyes are involved, both eyes would be eligible for the study.

  • Willing and able to comply with clinic visits and study related procedures.

  • Willing and able to sign the informed consent form.

Exclusion Criteria:
  • Patients under age 18.

  • Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).

  • Active infectious ocular or systemic disease.

  • Patients with active infectious ocular or extraocular disease.

  • Patients actively treated with local or systemic immunosuppression

  • 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:

  • Systemic corticosteroids - 2 weeks (see exception 5c)

  • Systemic NSAID over 375 mg per day - 2 weeks

  • Periocular/intraocular injection of any corticosteroid solution - 4 weeks (see exception 5b)

  • Corticosteroid depot/implant in the study eye - 2 months

  • Topical ocular corticosteroid - 7 days

  • Topical ocular NSAID - 7 days

  • 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.

  • Intraoperatively or perioperatively used systemic steroid for the purpose of general anesthesia (as administered by the treating anesthesiologist) is permissible.

  • Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.

  • Patients with known hypersensitivity to Dexamethasone.

  • Patients with uncontrolled glaucoma.

  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Retina Vitreous Surgeons of Central New York, PCLiverpoolNew YorkUnited States13088

Sponsors and Collaborators

  • Patrick R. Oellers, MD
  • Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patrick R. Oellers, MD, Principal Investigator, Retina Vitreous Surgeons of Central New York, PC
ClinicalTrials.gov Identifier:
NCT04462523
Other Study ID Numbers:
  • The ADHERE Study
First Posted:
Jul 8, 2020
Last Update Posted:
Jul 8, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2020