Rhegmatogenous Retinal DetachmentPhase 3NCT00370201
Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
A Phase 3 study testing colchicine in people with Rhegmatogenous Retinal Detachment, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- colchicine
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Mar 2004to Aug 2006
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rhegmatogenous retinal detachment
Who cannot join
- PVR grade C
- Duration of retinal detachment ≥ one month
- History of cataract surgery
- History of RD surgery
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- colchicine
- Keywords
- retinal detachment, proliferative vitreoretinopathy
- Medical subject headings
- Retinal Detachment, Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colchicineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
proliferative vitreoretinopathy
retinal reattachment rate
Secondary outcomes (3)
visual acuity
reoperation
macular pucker
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startMar 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies 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
- NCT00370201
- Sponsor's protocol ID
- 8259
- Status last verified
- Mar 2004
- First submitted
- 30 Aug 2006
- Last updated
- 9 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT00370201
- Acronym / sponsor ID
- 8259
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- retinal detachment, proliferative vitreoretinopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Aug 2006
- First posted
- 31 Aug 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.
This clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rhegmatogenous retinal detachment
Key exclusion criteria (4 listed)
- PVR grade C
- Duration of retinal detachment ≥ one month
- History of cataract surgery
- History of RD surgery
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 |
|---|---|---|
| colchicine | Drug | – |
Primary outcome
proliferative vitreoretinopathy
retinal reattachment rate
3 secondary outcomes
visual acuity
reoperation
macular pucker
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2006.
Related trials for Rhegmatogenous Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Active, not recruiting
Ocular Hypotony and Refractive Predictability in RRD Surgery
Rhegmatogenous Retinal Detachment, Hypotony Ocular
RecruitingPhase 1/2
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy
Not yet recruitingPhase 1
The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy
Proliferative Vitreoretinopathy, Proliferative Vitreo-Retinopathy
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 colchicine in people with Rhegmatogenous Retinal Detachment, 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: status not confirmed, as of the sponsor's last update on 9 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?
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?
proliferative vitreoretinopathy. 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 9 Oct 2006.