Proliferative VitreoretinopathyPhase 3NCT00370760
Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)
A Phase 3 study testing oral colchicine, dexamethasone, 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 efficacy of oral colchicine combined with intraoperative infusion of dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of established proliferative vitreoretinopathy (PVR) Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Proliferative Vitreoretinopathy
- What is being tested?
- oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Sep 2006to not given
- 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases with rhegmatogenous retinal detachment complicated by PVR grade C
Who cannot join
- History of pars plana vitrectomy for PVR grade C
- History of silicone oil injection
- History of ocular trauma
- Diabetic retinopathy
- Glaucoma
- Giant retinal tear
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Hamid Ahmadieh, MD
Tehran, Tehran Province, 16666
Hamid Ahmadieh, MD, +98 21 22585952, hahmadieh@hotmail.com
About this study
To evaluate the efficacy of oral colchicine combined with intraoperative infusion of dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of established proliferative vitreoretinopathy (PVR)
- Conditions
- Proliferative Vitreoretinopathy
- Being tested
- oral colchicine, dexamethasone, low molecular weight heparin, 5-FU, placebo
- Keywords
- PVR, Oral colchicine, Dexamethasone, 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.
oral colchicine, dexamethasone, low molecular weight heparin, 5-FUDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal reattachment rate
Secondary outcomes (5)
PVR recurrence,
macular pucker,
reoperation,
ocular hypotony,
visual acuity
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 startSep 2006
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
- Who is masked
- Participant, Outcomes assessor
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
- NCT00370760
- Sponsor's protocol ID
- 8404
- Status last verified
- Jun 2008
- First submitted
- 30 Aug 2006
- Last updated
- 26 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)
- ClinicalTrials.gov ID
- NCT00370760
- Acronym / sponsor ID
- 8404
- Conditions
- Proliferative Vitreoretinopathy
- Keywords
- PVR, Oral colchicine, Dexamethasone, 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
- Sep 2006
- 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 efficacy of oral colchicine combined with intraoperative infusion of dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of established proliferative vitreoretinopathy (PVR)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cases with rhegmatogenous retinal detachment complicated by PVR grade C
Key exclusion criteria (6 listed)
- History of pars plana vitrectomy for PVR grade C
- History of silicone oil injection
- History of ocular trauma
- Diabetic retinopathy
- Glaucoma
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 |
|---|---|---|
| oral colchicine, dexamethasone, low molecular weight heparin, 5-FU | Drug | 1 |
| placebo | Drug | 2 |
Primary outcome
Retinal reattachment rate
5 secondary outcomes
PVR recurrence,
macular pucker,
reoperation,
ocular hypotony,
visual acuity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2008.
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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 oral colchicine, dexamethasone, 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 6 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 26 Jun 2008. 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. Some participants in this study may receive a placebo. 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?
Contact Hamid Ahmadieh, MD (+98 21 22585952, hahmadieh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal reattachment 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 26 Jun 2008.