Macular DegenerationNCT01204541
A Single-Center Pilot Study to Assess Macular Function
An observational study of Macular Degeneration, run by ORA, Inc. at 1 site in United States.
Trial summary
This study seeks to evaluate a novel endpoint for future dry AMD clinical trials. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2010
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three groups of subjects will be enrolled: 1. Normal healthy subjects aged 20-29 years 2. Normal healthy subjects aged 60-90 years 3. Subjects with early dry AMD
Who may be able to join
- Subjects in good health aged 20-29 or 60-90 years (normal cohorts)
- Subjects with early non-exudative age-related macular degeneration (AMD cohort)
Who cannot join
- Enrollment in a investigational drug or device study and have used an investigational drug or device within 7 days of enrollment into this study
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to evaluate a novel endpoint for future dry AMD clinical trials.
- Conditions
- Macular Degeneration
- Keywords
- Non-exudative age-related macular degeneration
- 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 |
|---|---|---|
| AMD | Not described | |
| Young normals | Not described | |
| Older normals | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204541
- Sponsor's protocol ID
- 10-120-0013
- Status last verified
- Feb 2012
- First submitted
- 16 Sep 2010
- Last updated
- 14 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Pilot Study to Assess Macular Function
- ClinicalTrials.gov ID
- NCT01204541
- Acronym / sponsor ID
- 10-120-0013
- Conditions
- Macular Degeneration
- Keywords
- Non-exudative age-related macular degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Sep 2010 (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 study seeks to evaluate a novel endpoint for future dry AMD clinical trials.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMD | – | – |
| Young normals | – | – |
| Older normals | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three groups of subjects will be enrolled: 1. Normal healthy subjects aged 20-29 years 2. Normal healthy subjects aged 60-90 years 3. Subjects with early dry AMD
Key inclusion criteria (2 listed)
- Subjects in good health aged 20-29 or 60-90 years (normal cohorts)
- Subjects with early non-exudative age-related macular degeneration (AMD cohort)
Key exclusion criteria (1 listed)
- Enrollment in a investigational drug or device study and have used an investigational drug or device within 7 days of enrollment into this study
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Macular Degeneration, run by ORA, Inc. at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 14 Feb 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 14 Feb 2012.