VitrectomyPhase 3NCT00532415
Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy
A Phase 3 study testing Triamcinolone Acetonide Injectable Suspension in people with Vitrectomy, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide suspension when used for visualization of structures in the back of the eye during eye surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitrectomy
- What is being tested?
- Triamcinolone Acetonide Injectable Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Sep 2007
- Phase
- Phase 3
- 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
- Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Patients under 18.
- Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery
The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide suspension when used for visualization of structures in the back of the eye during eye surgery.
- Conditions
- Vitrectomy
- Being tested
- Triamcinolone Acetonide Injectable Suspension
- Keywords
- Vitrectomy, Visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide Injectable SuspensionDrug
Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone | Experimental | Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal. Receives: Drug: Triamcinolone Acetonide Injectable Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Visualization Score at Post-Instillation from Pre-Instillation
A video image of the posterior segment structures of the eye was taken before instillation of the test product and after. An independent masked reader evaluated the images and graded the degree of visualization on a 5-point scale ranging from 1 to 4 and anchored at the ends by "Not Visible (0)" and "Clearly Delineated (4)." The mean difference was calculated, and a higher number indicated increased visibility.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2007
- Study completionSep 2007
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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532415
- Sponsor's protocol ID
- C-05-62
- Status last verified
- Apr 2012
- First submitted
- 19 Sep 2007
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery
- ClinicalTrials.gov ID
- NCT00532415
- Acronym / sponsor ID
- C-05-62
- Conditions
- Vitrectomy
- Keywords
- Vitrectomy, Visualization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Sep 2007 (estimated)
- 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 the safety and efficacy of triamcinolone acetonide suspension when used for visualization of structures in the back of the eye during eye surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone | Experimental | Drug: Triamcinolone Acetonide Injectable SuspensionApproximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Patients under 18.
- Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Triamcinolone Acetonide Injectable SuspensionApproximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal. | Drug | Triamcinolone |
Primary outcome
Change in Mean Visualization Score at Post-Instillation from Pre-Instillation
Time frame: Day 0
A video image of the posterior segment structures of the eye was taken before instillation of the test product and after. An independent masked reader evaluated the images and graded the degree of visualization on a 5-point scale ranging from 1 to 4 and anchored at the ends by "Not Visible (0)" and "Clearly Delineated (4)." The mean difference was calculated, and a higher number indicated increased visibility.
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 5 Apr 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triamcinolone Acetonide Injectable Suspension in people with Vitrectomy, run by Alcon Research.
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 2 inclusion and 3 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 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in Mean Visualization Score at Post-Instillation from Pre-Instillation (time frame: Day 0). 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 5 Apr 2012.