Age-Related Macular DegenerationNCT00599846
The Natural History of Geographic Atrophy Progression (GAP) Study
An observational study of Age-Related Macular Degeneration and Geographic Atrophy, run by Alcon Research at 1 site in United States.
Trial summary
The objective of the 18-month trial is to evaluate the natural history of geographic atrophy by assessing the rate of progression of the geographic atrophic lesion over time. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Geographic Atrophy
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2009
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients showing signs of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.
Who may be able to join
- Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.
Who cannot join
- Age related
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the 18-month trial is to evaluate the natural history of geographic atrophy by assessing the rate of progression of the geographic atrophic lesion over time.
- Keywords
- age-related macular degeneration, geographic atrophy
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
GA progression rate using fundus autofluorescence
Measured: From baseline
Secondary outcomes (1)
GA progression rate using fundus photography
Measured: From baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patricia Zilliox, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599846
- Sponsor's protocol ID
- C-06-30
- Status last verified
- Feb 2010
- First submitted
- 13 Jan 2008
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Steinberg JS, Auge J, Jaffe GJ, Fleckenstein M, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Longitudinal analysis of reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2013 Jun 10;54(6):4054-60. doi: 10.1167/iovs.12-11538.
PubMed 23633663Mauschitz MM, Fonseca S, Chang P, Gobel AP, Fleckenstein M, Jaffe GJ, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Topography of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2012 Jul 26;53(8):4932-9. doi: 10.1167/iovs.12-9711.
PubMed 22661483Schmitz-Valckenberg S, Alten F, Steinberg JS, Jaffe GJ, Fleckenstein M, Mukesh BN, Hohman TC, Holz FG; Geographic Atrophy Progression (GAP) Study Group. Reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Aug 24;52(9):5009-15. doi: 10.1167/iovs.11-7235.
PubMed 21498612Schmitz-Valckenberg S, Fleckenstein M, Gobel AP, Hohman TC, Holz FG. Optical coherence tomography and autofluorescence findings in areas with geographic atrophy due to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Jan 5;52(1):1-6. doi: 10.1167/iovs.10-5619.
PubMed 20688734
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Geographic Atrophy Progression (GAP) Study
- ClinicalTrials.gov ID
- NCT00599846
- Acronym / sponsor ID
- C-06-30
- Keywords
- age-related macular degeneration, geographic atrophy
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- First posted
- 24 Jan 2008 (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 objective of the 18-month trial is to evaluate the natural history of geographic atrophy by assessing the rate of progression of the geographic atrophic lesion over time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients showing signs of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.
Key inclusion criteria (1 listed)
- Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.
Key exclusion criteria (1 listed)
- Age related
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
GA progression rate using fundus autofluorescence
Time frame: From baseline
1 secondary outcome
GA progression rate using fundus photography
Time frame: From baseline
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Derived from this study: PubMed 23633663Steinberg JS, Auge J, Jaffe GJ, Fleckenstein M, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Longitudinal analysis of reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2013 Jun 10;54(6):4054-60. doi: 10.1167/iovs.12-11538.
- Derived from this study: PubMed 22661483Mauschitz MM, Fonseca S, Chang P, Gobel AP, Fleckenstein M, Jaffe GJ, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Topography of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2012 Jul 26;53(8):4932-9. doi: 10.1167/iovs.12-9711.
- Derived from this study: PubMed 21498612Schmitz-Valckenberg S, Alten F, Steinberg JS, Jaffe GJ, Fleckenstein M, Mukesh BN, Hohman TC, Holz FG; Geographic Atrophy Progression (GAP) Study Group. Reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Aug 24;52(9):5009-15. doi: 10.1167/iovs.11-7235.
- Derived from this study: PubMed 20688734Schmitz-Valckenberg S, Fleckenstein M, Gobel AP, Hohman TC, Holz FG. Optical coherence tomography and autofluorescence findings in areas with geographic atrophy due to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Jan 5;52(1):1-6. doi: 10.1167/iovs.10-5619.
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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.
Patricia Zilliox study director
Alcon Research
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 and Geographic Atrophy, run by Alcon Research 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 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: stopped early, as of the sponsor's last update on 2 Mar 2010. 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 was stopped early. 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?
GA progression rate using fundus autofluorescence (time frame: From baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00599846, which also lists 4 linked publications.
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 2 Mar 2010.