Age Related Macular DegenerationNCT01541449
Plaqenil Role in Prevention of Age Related Macular Degeneration
An observational study of Age Related Macular Degeneration, run by Ziv Hospital at 1 site in Israel.
Trial summary
The investigators think that there is a connection between the use of plaquenil and the prevention of Age related macular degeneration (AMD). The investigators believe that the use of plaquenil makes bruch's membrane thicker, thereby preventing Chroidal Neovascularization (CNV) growth. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Apr 2012
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ziv Medical center retina clinic population
Who may be able to join
- all people who suffer from rheumatoid arthritis (RA) and use plaquenil
Who cannot join
- patients who did not complete follow-up
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical Center
Safed, 13100
Otzem Chassid, M.D, 0506266059, otzem@yahoo.com
About this study
Official title: Observational Study Between People That Use Plaquenil and Those Who do Not in Prevention of AMD.
The investigators think that there is a connection between the use of plaquenil and the prevention of Age related macular degeneration (AMD). The investigators believe that the use of plaquenil makes bruch's membrane thicker, thereby preventing Chroidal Neovascularization (CNV) growth.
Read the detailed description
the study is done by comparing to groups RA patients who take plaquenil Vs. group of patients who do not take plaquenil. after measuring the retina thickness we compare the avg. thickness of both groups.
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD, PLAQUENIL, CNV
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RA patients treated with plaquenil | Not described | |
| Patients who do not use plaquenil | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startJan 2012
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Joseph pikkel, M.D, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541449
- Sponsor's protocol ID
- ZIV-0061-11
- Status last verified
- Jan 2012
- First submitted
- 2 Feb 2012
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Between People That Use Plaquenil and Those Who do Not in Prevention of AMD.
- ClinicalTrials.gov ID
- NCT01541449
- Acronym / sponsor ID
- ZIV-0061-11
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD, PLAQUENIL, CNV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Jan 2012
- Study completion
- Apr 2012 (estimated)
- First posted
- 1 Mar 2012 (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.
The investigators think that there is a connection between the use of plaquenil and the prevention of Age related macular degeneration (AMD). The investigators believe that the use of plaquenil makes bruch's membrane thicker, thereby preventing Chroidal Neovascularization (CNV) growth.
Detailed description
the study is done by comparing to groups RA patients who take plaquenil Vs. group of patients who do not take plaquenil. after measuring the retina thickness we compare the avg. thickness of both groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients treated with plaquenil | – | – |
| Patients who do not use plaquenil | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ziv Medical center retina clinic population
Key inclusion criteria (1 listed)
- all people who suffer from rheumatoid arthritis (RA) and use plaquenil
Key exclusion criteria (1 listed)
- patients who did not complete follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 1 Mar 2012.
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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.
Joseph pikkel, M.D principal investigator
Ziv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Ziv Hospital at 1 site in Israel.
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 1 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 1 Mar 2012. 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 Israel. 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?
Contact Joseph Pikkel, M.D (0508434206, pikel.y@ziv.health.gov.il), or a site near the patient. 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 1 Mar 2012.