ChorioretinitisPhase 3NCT00372294
To Compare Intravitreal Clindamycin & Dexamethasone With Classic Treatment of Toxoplasmic Retinochoroiditis
A Phase 3 study testing pyrimethamine-sulfadiazine + prednisolone and Clindamycin+Dexamethasone in people with Chorioretinitis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Toxoplasmosis, an intra cellular parasite, is a very important cause of chorioretinitis. The goal of treatment is arresting multiplication of the parasite in its inflammatory active phase. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chorioretinitis
- What is being tested?
- pyrimethamine-sulfadiazine + prednisolone and Clindamycin+Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Jul 2005to Nov 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Toxoplasmic chorioretinitis
- Location of the lesion within zone I of the retina or a lesion greater than 2DD with 3+-4+ vitreous inflammation in zone II or III
- No allergic history to the used drugs
- No any other diseases
Who cannot join
- Any allergic reaction to the used medications
- One eyed patients
- Partially treated patients
Trial locations and contacts
1 site in 1 country.
About this study
Toxoplasmosis, an intra cellular parasite, is a very important cause of chorioretinitis. The goal of treatment is arresting multiplication of the parasite in its inflammatory active phase. In this study the investigators try to compare the efficacy of the classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon) with intravitreal Clindamycin \& Dexamethasone.
- Conditions
- Chorioretinitis
- Being tested
- pyrimethamine-sulfadiazine + prednisolone, Clindamycin+Dexamethasone
- Keywords
- Toxoplasmosis, Chorioretinitis, Intravitreal Clindamycin, Dexamethasone in chorioretinitis, Toxoplasmic
- Medical subject headings
- Chorioretinitis, Toxoplasmosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrimethamine-sulfadiazine + prednisoloneDrug
Administration of pyrimethamine-sulfadiazine + prednisolone
Clindamycin+DexamethasoneDrug
Intravitreal injection of Clindamycin+Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon) Receives: Drug: pyrimethamine-sulfadiazine + prednisolone |
| 2 | Active comparator | Intravitreal Clindamycin \& Dexamethasone Receives: Drug: Clindamycin+Dexamethasone |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startJul 2005
- Primary completionAug 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChorioretinitisStudies 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
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Masoud Soheilian, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372294
- Sponsor's protocol ID
- 8415
- Status last verified
- Jun 2008
- First submitted
- 5 Sep 2006
- Last updated
- 30 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Intravitreal Clindamycin & Dexamethasone With Classic Treatment of Toxoplasmic Retinochoroiditis
- ClinicalTrials.gov ID
- NCT00372294
- Acronym / sponsor ID
- 8415
- Conditions
- Chorioretinitis
- Keywords
- Toxoplasmosis, Chorioretinitis, Intravitreal Clindamycin, Dexamethasone in chorioretinitis, Toxoplasmic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 6 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.
Toxoplasmosis, an intra cellular parasite, is a very important cause of chorioretinitis. The goal of treatment is arresting multiplication of the parasite in its inflammatory active phase. In this study the investigators try to compare the efficacy of the classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon) with intravitreal Clindamycin \& Dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: pyrimethamine-sulfadiazine + prednisoloneClassic regimen (Pyrimethamine-Sulfadiazine + Prednisolon) |
| 2 | Active comparator | Drug: Clindamycin+DexamethasoneIntravitreal Clindamycin \& Dexamethasone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Toxoplasmic chorioretinitis
- Location of the lesion within zone I of the retina or a lesion greater than 2DD with 3+-4+ vitreous inflammation in zone II or III
- No allergic history to the used drugs
- No any other diseases
Key exclusion criteria (3 listed)
- Any allergic reaction to the used medications
- One eyed patients
- Partially treated patients
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 |
|---|---|---|
| pyrimethamine-sulfadiazine + prednisoloneAdministration of pyrimethamine-sulfadiazine + prednisolone | Drug | 1 |
| Clindamycin+DexamethasoneIntravitreal injection of Clindamycin+Dexamethasone | Drug | 2 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
Related trials for Chorioretinitis
RecruitingObservational study
Birdshot Chorioretinopathy : Prospective Follow-up and Immunogenetic Studies(CO-BIRD)
Birdshot Chorioretinopathy, Posterior Uveitis
RecruitingObservational study
Quantification & Classification of Inflammatory Cells in Uveitis Using OCT
Anterior Uveitis (AU), Birdshot Chorioretinitis
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.
Masoud Soheilian, 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 pyrimethamine-sulfadiazine + prednisolone and Clindamycin+Dexamethasone in people with Chorioretinitis, 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 4 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: status not confirmed, as of the sponsor's last update on 30 Jul 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. 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.
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 30 Jul 2008.