Uveitis, PosteriorNCT03145025
Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
An observational study of Uveitis, Posterior, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated with a Fluocinolone Acetonide Intravitreal Implant Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Uveitis, Posterior
- What is being tested?
- Retisert and Fluocinolone Acetonide Intravitreal Implant
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2017to 22 Mar 2019
- Phase
- Observational
- 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects having the Retisert FA drug delivery system (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year
Who may be able to join
- Are scheduled for surgical placement of a Retisert fluocinolone acetonide (FA) intravitreal implant in a previously unimplanted eye.
- Are able and willing to comply with all treatment and follow up/study procedures.
- Able and willing to provide informed consent or, for subjects 12-18 years of age, have the ability to understand and provide assent (when applicable) and whose parent/legally authorized representative has the ability to understand and provide written informed consent on the Institutional Review Board (IRB) approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- For female subjects:
- Note: Should a subject conceive during the study, the pregnancy should be reported as soon as possible to the study Medical Monitor and Promedica International within 24 hours. The pregnancy will be followed up to term. The subject will continue in the studyregardless if pregnancy is reported on an AE/SAE form. If an Investigator becomes aware of a post study pregnancy 30 days after the study exit visit while Fluocinolone Acetonide Implant remains in the subject's study eye, then it should be reported as a post-marketing report
Who cannot join
- Has previously, concurrently or anticipated enrollment in Bausch \& Lomb study 440, titled, "An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year."
- Has severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study, based on the judgment of the Investigator.
- Has participated in an ophthalmic drug or device research study within 30 days prior to Screening (Visit 1, Day -30 to -1) in this study
- Is monocular (unable to detect hand motion at 6 feet in 1 eye).
- Has a known corneal dystrophy or corneal transplant.
- Has a history of ocular surgery in the eye scheduled for implant surgery, including laser procedures, within the 30 days prior to Screening (Visit 1, Day -30 to -1).
- Had any type of intraocular drug delivery implant (eg, Retisert, Ozurdex [dexamethasone intravitreal implant]) in the study eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated with a Fluocinolone Acetonide Intravitreal Implant
Read the detailed description
This is a prospective, multicenter, open-label, single arm, observational evaluation of the corneal ECD change from baseline for subjects having the Retisert FA drug delivery system (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year.
- Conditions
- Uveitis, Posterior
- Being tested
- Retisert, Fluocinolone Acetonide Intravitreal Implant
- Medical subject headings
- Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetisertDevice
Intravitreal Implant
Fluocinolone Acetonide Intravitreal ImplantDrug
Intravitreal Implant
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint is change from baseline in endothelial cell density (ECD) in the study eye one year following implantation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start14 Jul 2017
- Primary completion10 Sep 2018
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145025
- Sponsor's protocol ID
- 853
- Status last verified
- Jun 2019
- First submitted
- 25 Apr 2017
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
- ClinicalTrials.gov ID
- NCT03145025
- Acronym / sponsor ID
- 853
- Conditions
- Uveitis, Posterior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 9 May 2017 (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.
An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated with a Fluocinolone Acetonide Intravitreal Implant
Detailed description
This is a prospective, multicenter, open-label, single arm, observational evaluation of the corneal ECD change from baseline for subjects having the Retisert FA drug delivery system (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects having the Retisert FA drug delivery system (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year
Key inclusion criteria (5 listed)
- Are scheduled for surgical placement of a Retisert fluocinolone acetonide (FA) intravitreal implant in a previously unimplanted eye.
- Are able and willing to comply with all treatment and follow up/study procedures.
- Able and willing to provide informed consent or, for subjects 12-18 years of age, have the ability to understand and provide assent (when applicable) and whose parent/legally authorized representative has the ability to understand and provide written informed consent on the Institutional Review Board (IRB) approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- For female subjects:
- Note: Should a subject conceive during the study, the pregnancy should be reported as soon as possible to the study Medical Monitor and Promedica International within 24 hours. The pregnancy will be followed up to term. The subject will continue in the studyregardless if pregnancy is reported on an AE/SAE form. If an Investigator becomes aware of a post study pregnancy 30 days after the study exit visit while Fluocinolone Acetonide Implant remains in the subject's study eye, then it should be reported as a post-marketing report
Key exclusion criteria (7 listed)
- Has previously, concurrently or anticipated enrollment in Bausch \& Lomb study 440, titled, "An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year."
- Has severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study, based on the judgment of the Investigator.
- Has participated in an ophthalmic drug or device research study within 30 days prior to Screening (Visit 1, Day -30 to -1) in this study
- Is monocular (unable to detect hand motion at 6 feet in 1 eye).
- Has a known corneal dystrophy or corneal transplant.
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 |
|---|---|---|
| RetisertIntravitreal Implant | Device | – |
| Fluocinolone Acetonide Intravitreal ImplantIntravitreal Implant | Drug | – |
Primary outcome
The primary safety endpoint is change from baseline in endothelial cell density (ECD) in the study eye one year following implantation.
Time frame: 1 year
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 21 Jun 2019.
- Individual participant dataSharing planned: Yes
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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.
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?
An observational study of Uveitis, Posterior, run by Bausch & Lomb Incorporated 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 5 inclusion and 7 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 21 Jun 2019. 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.
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?
The primary safety endpoint is change from baseline in endothelial cell density (ECD) in the study eye one year following implantation. (time frame: 1 year). 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 21 Jun 2019.