VitrectomyPhase 4NCT04501367
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.
A Phase 4 study testing Dexamethasone Intracanalicular Insert, 0.4 mg and Prednisone acetate 1% in people with Vitrectomy and Macular Pucker, run by Kovach Eye Institute at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitrectomy, Macular Pucker, Retinal Edema
- What is being tested?
- Dexamethasone Intracanalicular Insert, 0.4 mg and Prednisone acetate 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kovach Eye Institute
Elmhurst, Illinois, 60126
Jamie White, BA, 630-833-9361 ext. 129, jamie.white@kovacheye.com
Saad Ahmad, MD
About this study
Official title: Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) 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.
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
Read the detailed 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
- Conditions
- Vitrectomy, Macular Pucker, Retinal Edema
- Being tested
- Dexamethasone Intracanalicular Insert, 0.4 mg, Prednisone acetate 1%
- Medical subject headings
- Epiretinal Membrane, Papilledema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Intracanalicular Insert, 0.4 mgDrug
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 mgDrug
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%Drug
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery
| Study group | Role | What they receive |
|---|---|---|
| DEXTENZA Group | Experimental | Patients undergoing vitrectomy with internal limiting membrane peel Receives: Drug: Dexamethasone Intracanalicular Insert, 0.4 mg |
| Second DEXTENZA Group | Experimental | Patients undergoing vitrectomy with internal limiting membrane peel Receives: Drug: Dexamethasone Intracanalicular Insert, 0.4 mg |
| Topical Prednisolone Acetate 1% Group | Experimental | Patients undergoing vitrectomy with internal limiting membrane peel Receives: Drug: Prednisone acetate 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in retina edema
As measured by Optical Coherence Tomography (OCT)
Measured: assessed on day 30 and day 60
Secondary outcomes (4)
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
Measured: as assessed on days 1, 7, 30, 60
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
Measured: as assessed on days 1, 7, 30, 60
Mean Change in Best- Corrected Visual Acuity (BCVA)
as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart
Measured: from baseline at days 1, 7, 30, 60
Physician ease of Dextenza insertion
measured by a 0-10 scale
Measured: as assessed on day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start27 Apr 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitrectomyStudies 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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kovach Eye Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saad Ahmad, MD, Principal investigator, Kovach Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501367
- Sponsor's protocol ID
- Kovacheye
- Status last verified
- Jun 2023
- First submitted
- 30 Jul 2020
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) 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.
- ClinicalTrials.gov ID
- NCT04501367
- Acronym / sponsor ID
- Kovacheye
- Conditions
- Vitrectomy, Macular Pucker, Retinal Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kovach Eye InstituteIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Aug 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.
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| DEXTENZA Group | Experimental | Drug: Dexamethasone Intracanalicular Insert, 0.4 mgPatients undergoing vitrectomy with internal limiting membrane peel |
| Second DEXTENZA Group | Experimental | Drug: Dexamethasone Intracanalicular Insert, 0.4 mgPatients undergoing vitrectomy with internal limiting membrane peel |
| Topical Prednisolone Acetate 1% Group | Experimental | Drug: Prednisone acetate 1%Patients undergoing vitrectomy with internal limiting membrane peel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Dexamethasone Intracanalicular Insert, 0.4 mgTo 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 | Drug | DEXTENZA Group |
| Dexamethasone Intracanalicular Insert, 0.4 mgTo 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 | Drug | Second DEXTENZA Group |
| Prednisone acetate 1%To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery | Drug | Topical Prednisolone Acetate 1% Group |
Primary outcome
Mean change in retina edema
Time frame: assessed on day 30 and day 60
As measured by Optical Coherence Tomography (OCT)
4 secondary outcomes
Mean change in Inflammation ( Cell and Flare)
Time frame: as assessed on days 1, 7, 30, 60
Mean change in pain scores
Time frame: as assessed on days 1, 7, 30, 60
Mean Change in Best- Corrected Visual Acuity (BCVA)
Time frame: from baseline at days 1, 7, 30, 60
Physician ease of Dextenza insertion
Time frame: as assessed on day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Saad Ahmad, MD principal investigator
Kovach Eye Institute
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 Dexamethasone Intracanalicular Insert, 0.4 mg and Prednisone acetate 1% in people with Vitrectomy and Macular Pucker, run by Kovach Eye Institute 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?
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: status not confirmed, as of the sponsor's last update on 29 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saad Ahmad, MD (6308339361, ifixretinas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in retina edema (time frame: assessed on day 30 and day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2023.