Geographic AtrophyGAINNCT01694095
Evolution and Risk Factors Associated With Geographic Atrophy Progression
An observational study of Geographic Atrophy, run by Institut de la Macula y la Retina at 1 site in Spain.
Trial summary
Age-related macular degeneration is one of the leading causes of blindness worldwide. The factors that induce the progression of geographic atrophy, the advanced form of dry age-related macular degeneration, remain poorly understood. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2009to Aug 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with geographic atrophy
Who may be able to join
- Both sexes
- 50 years of age or older
- Uni or bilateral areas of geographic atrophy in the macula (as defined as areas devoid of retinal pigment epithelium measuring at least 0.5 disk areas on a 35º fundus photograph centered on field 2) secondary to age-related macular degeneration
- Willing to provide Informed consent
Who cannot join
- Other causes of geographic atrophy aside from age-related macular degeneration (ie, drug induced, central serous chorioretinopathy)
- Prior history of wet age-related macular degeneration
- Other significant concomitant macular diseases (ie, significant epiretinal membrane, stage II-IV macular hole)
- Previous treatment with macular laser photocoagulation, photodynamic therapy, antiangiogenic drugs or other treatments for wet age-related macular degeneration
- Intraocular surgery aside from phacoemulsification
- Inability to measure the full extent of the area of atrophy on a 35º fundus autofluorescence image centered on field 2
- Areas of geographic atrophy in direct contact with peripapillary areas of atrophy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Geographic Atrophy Progression in Patients With Age-related Macular Degeneration
Age-related macular degeneration is one of the leading causes of blindness worldwide. The factors that induce the progression of geographic atrophy, the advanced form of dry age-related macular degeneration, remain poorly understood. The aims of this study are to describe the natural history of geographic atrophy and identify potential risk factors associated with a faster spread of atrophy that may be used to develop rational therapies.
Read the detailed description
Age-related macular degeneration is the leading cause of blindness in developed countries. Geographic atrophy is the advanced form of dry age-related macular degeneration, and currently has no effective therapy. Little is known about the risk factors that drive the progression of geographic atrophy, and yet they are crucial to understand the mechanisms of the disease. Therefore, the identification of risk factors associated with a faster spread of atrophy may help contribute to identify the causes of the disease and, ultimately, to develop new therapeutic strategies to manage the disorder.
The current prospective, observational, natural history study has the following objectives:
- Describe the natural history of geographic atrophy in anatomic and visual terms
- Identify risk factors associated with a faster enlargement of atrophy
The main hypothesis is that lipofuscin accumulation at the borders of atrophy as seen with fundus autofluorescence imaging is associated with a faster progression of the disease.
- Conditions
- Geographic Atrophy
- Keywords
- Geographic atrophy, prognosis, risk factors, natural history
- Medical subject headings
- Geographic Atrophy
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 |
|---|---|---|
| Patients with geographic atrophy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2
For measures related to change in the area of atrophy, a multivariable model will be fit and will include as an independent variable (amongst other presumed risk factors) fundus autofluorescence patterns
Measured: From baseline to last follow-up
Secondary outcomes (1)
Median change in area of geographic atrophy as measured in square root of mm2 with fundus autofluorescence on a 30º image centered on field 2
Exploratory analysis, either in the main publication or in another paper
Measured: From baseline to last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startDec 2009
- Primary completionAug 2013
- Study completionAug 2013
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 Geographic AtrophyStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de la Macula y la Retina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Mones, Institut de la Macula y la Retina
- Investigators
- Jordi Monés, MD, PhD, Principal investigator, Institut de la màcula i de la retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694095
- Sponsor's protocol ID
- GAIN-002-10-2010
- Acronym
- GAIN
- Status last verified
- Mar 2015
- First submitted
- 22 Sep 2012
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Biarnes M, Mones J, Trindade F, Alonso J, Arias L. Intra and interobserver agreement in the classification of fundus autofluorescence patterns in geographic atrophy secondary to age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2012 Apr;250(4):485-90. doi: 10.1007/s00417-011-1846-y. Epub 2011 Oct 28.
PubMed 22033626Mones J, Biarnes M, Trindade F. Hyporeflective wedge-shaped band in geographic atrophy secondary to age-related macular degeneration: an underreported finding. Ophthalmology. 2012 Jul;119(7):1412-9. doi: 10.1016/j.ophtha.2012.01.026. Epub 2012 Mar 21.
PubMed 22440276Mones J, Biarnes M, Trindade F, Arias L, Alonso J. Optical coherence tomography assessment of apparent foveal swelling in patients with foveal sparing secondary to geographic atrophy. Ophthalmology. 2013 Apr;120(4):829-36. doi: 10.1016/j.ophtha.2012.09.054. Epub 2013 Jan 3.
PubMed 23290986Biarnes M, Forero CG, Arias L, Alonso J, Mones J. Reappraisal of geographic atrophy patterns seen on fundus autofluorescence using a latent class analysis approach. Invest Ophthalmol Vis Sci. 2014 Nov 18;55(12):8302-8. doi: 10.1167/iovs.13-13542.
PubMed 25406275
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Geographic Atrophy Progression in Patients With Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01694095
- Acronym / sponsor ID
- GAIN / GAIN-002-10-2010
- Conditions
- Geographic Atrophy
- Keywords
- Geographic atrophy, prognosis, risk factors, natural history
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Institut de la Macula y la RetinaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Sep 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.
Age-related macular degeneration is one of the leading causes of blindness worldwide. The factors that induce the progression of geographic atrophy, the advanced form of dry age-related macular degeneration, remain poorly understood. The aims of this study are to describe the natural history of geographic atrophy and identify potential risk factors associated with a faster spread of atrophy that may be used to develop rational therapies.
Detailed description
Age-related macular degeneration is the leading cause of blindness in developed countries. Geographic atrophy is the advanced form of dry age-related macular degeneration, and currently has no effective therapy. Little is known about the risk factors that drive the progression of geographic atrophy, and yet they are crucial to understand the mechanisms of the disease. Therefore, the identification of risk factors associated with a faster spread of atrophy may help contribute to identify the causes of the disease and, ultimately, to develop new therapeutic strategies to manage the disorder.
The current prospective, observational, natural history study has the following objectives:
- Describe the natural history of geographic atrophy in anatomic and visual terms
- Identify risk factors associated with a faster enlargement of atrophy
The main hypothesis is that lipofuscin accumulation at the borders of atrophy as seen with fundus autofluorescence imaging is associated with a faster progression of the disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with geographic atrophy | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with geographic atrophy
Key inclusion criteria (4 listed)
- Both sexes
- 50 years of age or older
- Uni or bilateral areas of geographic atrophy in the macula (as defined as areas devoid of retinal pigment epithelium measuring at least 0.5 disk areas on a 35º fundus photograph centered on field 2) secondary to age-related macular degeneration
- Willing to provide Informed consent
Key exclusion criteria (7 listed)
- Other causes of geographic atrophy aside from age-related macular degeneration (ie, drug induced, central serous chorioretinopathy)
- Prior history of wet age-related macular degeneration
- Other significant concomitant macular diseases (ie, significant epiretinal membrane, stage II-IV macular hole)
- Previous treatment with macular laser photocoagulation, photodynamic therapy, antiangiogenic drugs or other treatments for wet age-related macular degeneration
- Intraocular surgery aside from phacoemulsification
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
Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2
Time frame: From baseline to last follow-up
For measures related to change in the area of atrophy, a multivariable model will be fit and will include as an independent variable (amongst other presumed risk factors) fundus autofluorescence patterns
1 secondary outcome
Median change in area of geographic atrophy as measured in square root of mm2 with fundus autofluorescence on a 30º image centered on field 2
Time frame: From baseline to last follow-up
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 24 Mar 2015.
- Results publication: PubMed 22033626Biarnes M, Mones J, Trindade F, Alonso J, Arias L. Intra and interobserver agreement in the classification of fundus autofluorescence patterns in geographic atrophy secondary to age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2012 Apr;250(4):485-90. doi: 10.1007/s00417-011-1846-y. Epub 2011 Oct 28.
- Results publication: PubMed 22440276Mones J, Biarnes M, Trindade F. Hyporeflective wedge-shaped band in geographic atrophy secondary to age-related macular degeneration: an underreported finding. Ophthalmology. 2012 Jul;119(7):1412-9. doi: 10.1016/j.ophtha.2012.01.026. Epub 2012 Mar 21.
- Results publication: PubMed 23290986Mones J, Biarnes M, Trindade F, Arias L, Alonso J. Optical coherence tomography assessment of apparent foveal swelling in patients with foveal sparing secondary to geographic atrophy. Ophthalmology. 2013 Apr;120(4):829-36. doi: 10.1016/j.ophtha.2012.09.054. Epub 2013 Jan 3.
- Results publication: PubMed 25406275Biarnes M, Forero CG, Arias L, Alonso J, Mones J. Reappraisal of geographic atrophy patterns seen on fundus autofluorescence using a latent class analysis approach. Invest Ophthalmol Vis Sci. 2014 Nov 18;55(12):8302-8. doi: 10.1167/iovs.13-13542.
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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.
Jordi Monés, MD, PhD principal investigator
Institut de la màcula i de la retina
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 Geographic Atrophy, run by Institut de la Macula y la Retina at 1 site in Spain.
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 7 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 24 Mar 2015. 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 Spain. 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.
What does the primary outcome measure?
Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2 (time frame: From baseline to last follow-up). 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 NCT01694095, 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 24 Mar 2015.