Proliferative VitreoretinopathyPhase 3NCT00373282
Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy
A Phase 3 study testing Triamcinolone acetonide in people with Proliferative Vitreoretinopathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Proliferative Vitreoretinopathy
- What is being tested?
- Triamcinolone acetonide
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Jun 2001to Jun 2003
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cases of rhegmatogenous retinal detachment complicated by PVR grade C undergoing vitrectomy and silicone oil tamponade.
Who cannot join
- History of trauma
- Presence of diabetic retinopathy
- History of vein occlusion
- Giant retinal tear
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR.
- Conditions
- Proliferative Vitreoretinopathy
- Being tested
- Triamcinolone acetonide
- Keywords
- PVR, Retinal detachment, Silicone oil, Triamcinolone
- Medical subject headings
- Vitreoretinopathy, Proliferative, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-operation retinal reattachment rate six
months after surgery.
Secondary outcomes (4)
Visual acuity
Retinal reproliferation
Intraocular pressure
Early silicone oil emulsification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startJun 2001
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative VitreoretinopathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Hamid Ahmadieh, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373282
- Sponsor's protocol ID
- 8116
- Status last verified
- Aug 2006
- First submitted
- 7 Sep 2006
- Last updated
- 12 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy
- ClinicalTrials.gov ID
- NCT00373282
- Acronym / sponsor ID
- 8116
- Conditions
- Proliferative Vitreoretinopathy
- Keywords
- PVR, Retinal detachment, Silicone oil, Triamcinolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2001
- Study completion
- Jun 2003
- First posted
- 8 Sep 2006 (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.
To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cases of rhegmatogenous retinal detachment complicated by PVR grade C undergoing vitrectomy and silicone oil tamponade.
Key exclusion criteria (4 listed)
- History of trauma
- Presence of diabetic retinopathy
- History of vein occlusion
- Giant retinal tear
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 | Drug | – |
Primary outcome
Single-operation retinal reattachment rate six
months after surgery.
4 secondary outcomes
Visual acuity
Retinal reproliferation
Intraocular pressure
Early silicone oil emulsification
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 12 Oct 2006.
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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.
Hamid Ahmadieh, MD principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triamcinolone acetonide in people with Proliferative Vitreoretinopathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 4 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 12 Oct 2006. 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 Iran. 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 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?
Single-operation retinal reattachment rate six. 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 12 Oct 2006.