Vitreo-Retinal SurgeryPhase 4NCT04462523

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

A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Topical Prednisolone in people with Vitreo-Retinal Surgery, run by Patrick R. Oellers, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Any age
Conditions the study is for: Vitreo-Retinal Surgery
What is being tested?: Dextenza 0.4Mg Ophthalmic Insert and Topical Prednisolone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 3 Jan 2020to 31 Mar 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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:

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, 13088

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Vitreo-Retinal Surgery
Being tested: Dextenza 0.4Mg Ophthalmic Insert, Topical Prednisolone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dextenza 0.4Mg Ophthalmic InsertDrug
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.
Topical PrednisoloneDrug
Standard of care topical drop treatment

Study groups in NCT04462523
Study group	Role	What they receive
Group 1 Pre-surgery Dextenza insert	Experimental	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. Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert
Group 2 Surgery Day Dextenza insert	Experimental	Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops. Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert
Group 3 Post op Day 1 Dextenza insert	Experimental	Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert
Group 4 Topical steroid	Active comparator	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. Receives: Drug: Topical Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean cells as assessed by investigator in anterior chamber of the study eye
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Measured: Assessed at Day 14
Mean pain as reported by subject in the study eye: Visual Analog Scale
As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
Measured: Assessed at Day 28

Secondary outcomes (5)

Mean anterior chamber flare
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Measured: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Time to absence of cells
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Measured: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Time to absence of pain
As measure by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
Measured: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Proportion of rescue treatment
As measure by Concomitant Medications as rescue therapy
Measured: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Assessment of Dextenza ease of insertion
As measured by Ease of Use Survey (0=very easy to 10=very hard)
Measured: Assessed at Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 202031 Mar 2022

First posted8 Jul 2020
Study start3 Jan 2020
Primary completion31 Mar 2022
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vitreo-Retinal SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04462523
Sponsor's protocol ID: The ADHERE Study
Status last verified: Jun 2023
First submitted: 24 Jun 2020
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ueberroth JA, Oellers PR, Brown J, Rosenberg KI, Breazzano MP. Intracanalicular Dexamethasome Insert after Retinal Surgery: the ADHERE Trial. Ophthalmol Retina. 2023 Sep;7(9):831-833. doi: 10.1016/j.oret.2023.06.011. Epub 2023 Jun 24. No abstract available.
PubMed 37356492

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04462523
Acronym / sponsor ID: The ADHERE Study
Conditions: Vitreo-Retinal Surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Patrick R. Oellers, MDResearch network
Collaborators: Ocular Therapeutix, Inc.
Study start: 3 Jan 2020 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 8 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1 Pre-surgery Dextenza insert	Experimental	Drug: Dextenza 0.4Mg Ophthalmic InsertTen 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.
Group 2 Surgery Day Dextenza insert	Experimental	Drug: Dextenza 0.4Mg Ophthalmic InsertTen patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
Group 3 Post op Day 1 Dextenza insert	Experimental	Drug: Dextenza 0.4Mg Ophthalmic InsertTen patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops
Group 4 Topical steroid	Active comparator	Drug: Topical PrednisoloneTen 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dextenza 0.4Mg Ophthalmic InsertThe 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.	Drug	Group 1 Pre-surgery Dextenza insert, Group 2 Surgery Day Dextenza insert, Group 3 Post op Day 1 Dextenza insert
Topical PrednisoloneStandard of care topical drop treatment	Drug	Group 4 Topical steroid

Primary outcome

Mean cells as assessed by investigator in anterior chamber of the study eye
Time frame: 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
Time frame: Assessed at Day 28
As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)

5 secondary outcomes

Mean anterior chamber flare
Time frame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Time to absence of cells
Time frame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Time to absence of pain
Time frame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Proportion of rescue treatment
Time frame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Assessment of Dextenza ease of insertion
Time frame: Assessed at Day 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Derived from this study: PubMed 37356492Ueberroth JA, Oellers PR, Brown J, Rosenberg KI, Breazzano MP. Intracanalicular Dexamethasome Insert after Retinal Surgery: the ADHERE Trial. Ophthalmol Retina. 2023 Sep;7(9):831-833. doi: 10.1016/j.oret.2023.06.011. Epub 2023 Jun 24. No abstract available.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Topical Prednisolone in people with Vitreo-Retinal Surgery, run by Patrick R. Oellers, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean cells as assessed by investigator in anterior chamber of the study eye (time frame: Assessed at Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04462523, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.