Age-related Macular DegenerationNCT02372916
Geographic Atrophy and Intravitreal Ranibizumab Injections
An observational study of Age-related Macular Degeneration and Geographic Atrophy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Given the aging population who will be affected by wet AMD and lack of effective GA treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in AMD patients with GA, particularly the possible risk of GA development and enlargement. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Geographic Atrophy
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Nov 2016
- 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 both dry and wet-AMD
Who may be able to join
- Age > 50 years old
- Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD)
- Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients
- Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections.
- Able to maintain steady fixation in foveal and parafoveal area for fundus imaging Geographic atrophy (GA), both foveal-sparing and foveal GA. Foveal-sparing GA is defined as no GA within 250μm of the centre (Sunness et al. 1999)
- Area of GA can be imaged in its entirety and is not contiguous with areas of peripapillary atrophy
- Adequate media clarity for quality fundus images
Who cannot join
- Inability to undergo study procedures (e.g. contraindications to intravitreal injections) or attend follow-up visits CNV attributable to other causes than AMD
- Active intraocular inflammation
- Any other retinopathy, including diabetic retinopathy, retinal venous occlusion, epiretinal membrane
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Crystal Cheung, 416-603-5376, cheuncsy@gmail.com
Wai-Ching Lam
About this study
Official title: Progression of Geographic Atrophy and Intravitreal Injections of Ranibizumab Among Treated for Age-related Macular Degeneration
Given the aging population who will be affected by wet AMD and lack of effective GA treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in AMD patients with GA, particularly the possible risk of GA development and enlargement. This potential adverse effect has significant implication in the discussions with patients regarding the risks and benefits of AMD treatment and injection frequency. While monthly injections provide slight improvement of visual acuity at 2 years (Martin et al., 2012), the risk of GA enlargement may offset this benefit in visual acuity.
Previous studies assessed the association between intravitreal ranibizumab injections and de novo GA development in injection-naïve eyes (Martin et al, 2012, Querques et al., 2012., Grunwald et al., 2014), rather than GA enlargement in patients with preexisting GA. To the best of the investigators knowledge, there has been no prospective study assessing the association between intravitreal ranibizumab injections and rate of GA progression in patients with pre-existing GA. There is also no prospective study comparing the morphological features of GA between patients who are receiving intravitreal injections and those who are not, nor the concordance of GA enlargement rate between the 2 eyes among patients receiving and not receiving treatment.
- Being tested
- Ranibizumab
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
The medication Ranibizumab is routine standard of care for patients with wet AMD, and this is not an aspect of the study that is considered novel intervention
| Study group | Role | What they receive |
|---|---|---|
| Dry AMD | Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD) | |
| Wet AMD and treatment-naive | Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients Receives: Drug: Ranibizumab | |
| Wet AMD with history of intravitreal injections | Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geographic atrophy area progression
To assess the association between rate of geographic atrophy (GA) progression in age-related macular degeneration (AMD) and repeated intravitreal ranibizumab injections
Measured: Every 6 month for total of 2 years
Secondary outcomes (2)
Geographic atrophy morphological characteristics
To determine the difference of GA morphological characteristics between AMD patients receiving intravitreal injections and those who are not
Measured: Every 6 month for total of 2 years
Concordance of GA enlargement rate between the two eyes
To determine the concordance of GA enlargement rate between the two eyes for patients with bilateral GA
Measured: Every 6 month for total of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016 (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.
- More trials run by University Health Network, TorontoThe 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-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372916
- Sponsor's protocol ID
- 14-8235
- Status last verified
- Feb 2015
- First submitted
- 20 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Geographic Atrophy and Intravitreal Injections of Ranibizumab Among Treated for Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02372916
- Acronym / sponsor ID
- 14-8235
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (estimated)
- First posted
- 26 Feb 2015 (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.
Given the aging population who will be affected by wet AMD and lack of effective GA treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in AMD patients with GA, particularly the possible risk of GA development and enlargement. This potential adverse effect has significant implication in the discussions with patients regarding the risks and benefits of AMD treatment and injection frequency. While monthly injections provide slight improvement of visual acuity at 2 years (Martin et al., 2012), the risk of GA enlargement may offset this benefit in visual acuity.
Previous studies assessed the association between intravitreal ranibizumab injections and de novo GA development in injection-naïve eyes (Martin et al, 2012, Querques et al., 2012., Grunwald et al., 2014), rather than GA enlargement in patients with preexisting GA. To the best of the investigators knowledge, there has been no prospective study assessing the association between intravitreal ranibizumab injections and rate of GA progression in patients with pre-existing GA. There is also no prospective study comparing the morphological features of GA between patients who are receiving intravitreal injections and those who are not, nor the concordance of GA enlargement rate between the 2 eyes among patients receiving and not receiving treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry AMD | – | –Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD) |
| Wet AMD and treatment-naive | – | Drug: RanibizumabPatients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients |
| Wet AMD with history of intravitreal injections | – | Drug: RanibizumabPatients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with both dry and wet-AMD
Key inclusion criteria (7 listed)
- Age > 50 years old
- Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD)
- Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients
- Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections.
- Able to maintain steady fixation in foveal and parafoveal area for fundus imaging Geographic atrophy (GA), both foveal-sparing and foveal GA. Foveal-sparing GA is defined as no GA within 250μm of the centre (Sunness et al. 1999)
Key exclusion criteria (3 listed)
- Inability to undergo study procedures (e.g. contraindications to intravitreal injections) or attend follow-up visits CNV attributable to other causes than AMD
- Active intraocular inflammation
- Any other retinopathy, including diabetic retinopathy, retinal venous occlusion, epiretinal membrane
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 |
|---|---|---|
| RanibizumabThe medication Ranibizumab is routine standard of care for patients with wet AMD, and this is not an aspect of the study that is considered novel intervention | Drug | Wet AMD and treatment-naive, Wet AMD with history of intravitreal injections |
Primary outcome
Geographic atrophy area progression
Time frame: Every 6 month for total of 2 years
To assess the association between rate of geographic atrophy (GA) progression in age-related macular degeneration (AMD) and repeated intravitreal ranibizumab injections
2 secondary outcomes
Geographic atrophy morphological characteristics
Time frame: Every 6 month for total of 2 years
Concordance of GA enlargement rate between the two eyes
Time frame: Every 6 month for total of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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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.
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 University Health Network, Toronto at 1 site in Canada.
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 7 inclusion and 3 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 26 Feb 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 Canada. 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 Crystal Cheung, MD (416-603-5376, cheuncsy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geographic atrophy area progression (time frame: Every 6 month for total of 2 years). It is what the study was designed to measure, not a finding.
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 26 Feb 2015.