Proliferative VitreoretinopathyPhase 3NCT00371020
The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR
A Phase 3 study testing low molecular weight heparin, 5-FU 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 combined 5-FU and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (PVR). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Proliferative Vitreoretinopathy
- What is being tested?
- low molecular weight heparin, 5-FU
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Feb 2005to Jul 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases with history of vitrectomy and silicone oil injection for management of PVR who undergo silicone oil removal
Who cannot join
- any sign of retinal redetachment before silicone oil removal
- any sign of diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of combined 5-FU and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (PVR).
- Conditions
- Proliferative Vitreoretinopathy
- Being tested
- low molecular weight heparin, 5-FU
- Keywords
- silicone oil, PVR, retinal redetachment, low molecular weight heparin, 5-FU
- Medical subject headings
- Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low molecular weight heparin, 5-FUDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal redetachment rate
Secondary outcomes (4)
visual acuity
intraocular pressure
reoperation
relative afferent pupillary defect
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startFeb 2005
- Study completionJul 2007 (estimated)
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
- Double 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
- NCT00371020
- Sponsor's protocol ID
- 8373
- Status last verified
- Jul 2007
- First submitted
- 31 Aug 2006
- Last updated
- 12 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR
- ClinicalTrials.gov ID
- NCT00371020
- Acronym / sponsor ID
- 8373
- Conditions
- Proliferative Vitreoretinopathy
- Keywords
- silicone oil, PVR, retinal redetachment, low molecular weight heparin, 5-FU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Jul 2007 (estimated)
- First posted
- 1 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 combined 5-FU and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (PVR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cases with history of vitrectomy and silicone oil injection for management of PVR who undergo silicone oil removal
Key exclusion criteria (2 listed)
- any sign of retinal redetachment before silicone oil removal
- any sign of diabetic retinopathy
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 |
|---|---|---|
| low molecular weight heparin, 5-FU | Drug | – |
Primary outcome
Retinal redetachment rate
4 secondary outcomes
visual acuity
intraocular pressure
reoperation
relative afferent pupillary defect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2007.
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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 low molecular weight heparin, 5-FU 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 2 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: status not confirmed, as of the sponsor's last update on 12 Jul 2007. 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?
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?
Retinal redetachment rate. 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 Jul 2007.