Retinal DetachmentPhase 4NCT04464629
Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
A Phase 4 study testing Dextenza and Prednisolone Acetate in people with Retinal Detachment, run by Midwest Eye Institute at 1 site in United States.
Trial summary
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Dextenza and Prednisolone Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2020to 25 Jan 2023
- 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
Who may be able to join
- Pseudophakic
- Retinal Detachment
- Age 18 years and older
- Scheduled for gas bubble repair and laser surgery following retinal detachment
- 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 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
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- Patients being treated with immunomodulating agents in the study eye(s)
- Patients 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.
About this study
Official title: Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.
Read the detailed description
Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.
- Conditions
- Retinal Detachment
- Being tested
- Dextenza, Prednisolone Acetate
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextenzaDrug
Intracanalicular sustained release dexamethasone insert 0.4 mg
Prednisolone AcetateDrug
Topical Prednisolone acetate 1% ophthalmic suspension
| Study group | Role | What they receive |
|---|---|---|
| Intracanalicular Sustained Release Dexamethasone, 0.4 mg | Experimental | Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery. Receives: Drug: Dextenza |
| topical prednisolone acetate 1%. | Active comparator | Not described Receives: Drug: Prednisolone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in pain score
Average change in pain based on whats reported on the Ocular Pain Assessment
Measured: 30 Days
Post-op pain scores
Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.
Measured: 30 Days
Secondary outcomes (4)
Mean change in anterior chamber cell and flare score
Post op inflammation scores as measured on a scale of 0-4: Anterior Chamber Cell Count (Absence of cell to be defined as a grade of: 0-0.5, 4 being the maximum) and Anterior Chamber Flare Score (0 is the minimum, and 4 is the maximum). High reported cell and flare means a worse outcome.
Measured: 30 days
Cystoid Macular Edema
Amount of central thickness macular swelling as measured by Optical Coherence Tomography (OCT)
Measured: 30 days
Best Corrected Visual Acuity
As measured on ETDRS
Measured: 90 days
Physician Ease of Dextenza insertion
The investigator will grade the level of ease of insertion of the intracanalicular insert on a 0 to 10-point (0 being the minimum and 10 being the maximum) scale with 0 being very easy insertion and 10 being very hard. Difficult insertion means a worse outcome.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start14 Jul 2020
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Principal investigator, Neil Finnen, MD, Midwest Eye Institute
- Investigators
- Neil Finnen, MD, Principal investigator, Midwest Medical Advisors, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464629
- Sponsor's protocol ID
- The FINNEN Study
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2020
- Last updated
- 16 Aug 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 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
- ClinicalTrials.gov ID
- NCT04464629
- Acronym / sponsor ID
- The FINNEN Study
- Conditions
- Retinal Detachment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Midwest Eye InstituteUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 9 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.
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.
Detailed description
Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracanalicular Sustained Release Dexamethasone, 0.4 mg | Experimental | Drug: DextenzaIntracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery. |
| topical prednisolone acetate 1%. | Active comparator | Drug: Prednisolone Acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pseudophakic
- Retinal Detachment
- Age 18 years and older
- Scheduled for gas bubble repair and laser surgery following retinal detachment
- Willing and able to comply with clinic visits and study related procedures
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| DextenzaIntracanalicular sustained release dexamethasone insert 0.4 mg | Drug | Intracanalicular Sustained Release Dexamethasone, 0.4 mg |
| Prednisolone AcetateTopical Prednisolone acetate 1% ophthalmic suspension | Drug | topical prednisolone acetate 1%. |
Primary outcome
Mean change in pain score
Time frame: 30 Days
Average change in pain based on whats reported on the Ocular Pain Assessment
Post-op pain scores
Time frame: 30 Days
Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.
4 secondary outcomes
Mean change in anterior chamber cell and flare score
Time frame: 30 days
Cystoid Macular Edema
Time frame: 30 days
Best Corrected Visual Acuity
Time frame: 90 days
Physician Ease of Dextenza insertion
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Retinal Detachment
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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.
Neil Finnen, MD principal investigator
Midwest Medical Advisors, Inc
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 and Prednisolone Acetate in people with Retinal Detachment, run by Midwest 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?
The sponsor lists 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 Aug 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 was stopped early (reason given: Poor enrollment). Results are not available in the source record.
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 change in pain score (time frame: 30 Days). 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?
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 16 Aug 2023.