Retinitis PigmentosaNCT00433277
Autoimmunity in Retinitis Pigmentosa
A study testing twice-daily dosage with 0.5% cyclosporine-A eyedrops in people with Retinitis Pigmentosa, run by Semmelweis University at 1 site in Hungary.
Trial summary
Using local immune suppression, the trial seeks evidence for the hypothesis that autoimmunity plays a role in the pathomechanism of retinitis pigmentosa. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- twice-daily dosage with 0.5% cyclosporine-A eyedrops
- How many people
- Not given
- Where
- 1 siteHungary
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of retinitis pigmentosa
Who cannot join
- Cataract
- Extremely low ERG wave amplitude (less than 8% of normal)
Trial locations and contacts
1 site in 1 country.
About this study
Using local immune suppression, the trial seeks evidence for the hypothesis that autoimmunity plays a role in the pathomechanism of retinitis pigmentosa.
- Conditions
- Retinitis Pigmentosa
- Being tested
- twice-daily dosage with 0.5% cyclosporine-A eyedrops
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
twice-daily dosage with 0.5% cyclosporine-A eyedropsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Investigators
- Zoltán Z. Nagy, M.D., Study director, Semmelweis University, Dept. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433277
- Sponsor's protocol ID
- KMolnar
- Status last verified
- Feb 2007
- First submitted
- 6 Feb 2007
- Last updated
- 9 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoimmunity in Retinitis Pigmentosa
- ClinicalTrials.gov ID
- NCT00433277
- Acronym / sponsor ID
- KMolnar
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- First posted
- 9 Feb 2007 (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.
Using local immune suppression, the trial seeks evidence for the hypothesis that autoimmunity plays a role in the pathomechanism of retinitis pigmentosa.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of retinitis pigmentosa
Key exclusion criteria (2 listed)
- Cataract
- Extremely low ERG wave amplitude (less than 8% of normal)
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 |
|---|---|---|
| twice-daily dosage with 0.5% cyclosporine-A eyedrops | Drug | – |
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 9 Feb 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.
Zoltán Z. Nagy, M.D. study director
Semmelweis University, Dept. of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing twice-daily dosage with 0.5% cyclosporine-A eyedrops in people with Retinitis Pigmentosa, run by Semmelweis University at 1 site in Hungary.
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 9 Feb 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 Hungary. 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.
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 9 Feb 2007.