Wet Age-related Macular DegenerationNCT02005133
A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics
An observational study of Wet Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 17 sites in United Kingdom.
Trial summary
To assess the use of aflibercept over a 2 year period in VEGF inhibitor naive and prior treated wet AMD patients managed in 'real wold' clinic settings. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration
- How many people
- 188 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- Nov 2013to Oct 2015
- 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: Male and female subjects diagnosed with visual impairment due to wet AMD who are undergoing routine assessment in UK opthalmology clinics.
Who may be able to join
- Age greater or equal to 50 years Active choroidal neovascularisation secondary to AMD in one or both eyes which in the opinion of the investigator will benefit from treatment with aflibercept Subject willing and able to provide informed consent
Who cannot join
- Patients must not have had any prior use of either bevacizumab or aflibercept
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Novartis Investigative Site
Bolton, BL4 0JR
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
Bristol, BS1 2LX
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ
Novartis Investigative Site
Guildford, Surrey, GU2 5XX
Novartis Investigative Site
Kent, CT1 3NG
Novartis Investigative Site
Leeds, West Yorkshire, LS9 7TF
Novartis Investigative Site
Liverpool, L7 8XP
Novartis Investigative Site
London, United Kingdom, EC1V 2PD
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP
Novartis Investigative Site
Southampton, SO16 6YD
Novartis Investigative Site
Southend, SS0 0RY
Novartis Investigative Site
Sunderland, SR2 9HP
Novartis Investigative Site
Taunton, Somerset, TA1 5DA
Novartis Investigative Site
Uxbridge, UB8 3NN
Novartis Investigative Site
York, YO31 8HE
About this study
To assess the use of aflibercept over a 2 year period in VEGF inhibitor naive and prior treated wet AMD patients managed in 'real wold' clinic settings.
- Conditions
- Wet Age-related Macular Degeneration
- Keywords
- Wet age-related 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 |
|---|---|---|
| VEGF inhibitor naïve | Not described | |
| VEGF inhibitor prior treated | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of aflibercept administration
To assess the frequency of clinic visits over a 1 year period in VEGF inhibitor naive wet AMD patients managed in 'real world' clinic settings.
Measured: Up to 1 year
Secondary outcomes (4)
Frequency of clinic visits
To assess how frequently aflibercept is administered over a 2 year period to VEGF inhibitor naive wet AMD patients managed in 'real world' clinic settings and to determine how frequently these subjects are seen in the clinic.
Measured: Up to 1 year
Aflibercept Administration
To assess how frequently aflibercept is administered over 1 year and 2 year periods to prior treated VEGF inhibitor treated wet AMD subjects managed in 'real world' clinic settings and to determine how frequently these subjects are seen in the clinic.
Measured: Up to 2 years
Changes in visual acuity from baseline
To assess how visual acuity changes over 1 year and 2 year periods in both VEGF inhibitor naive and prior treated wet AMD subjects that receive aflibercept.
Measured: Up to 2 years
Change in central retinal thickness from baseline
To assess how central retinal thickness (CRT) changes as determined by optical coherence tomography OCT) over a 1 year and 2 year period in both VEGF inhibitor naive and prior treated wet AMD subjects that receive aflibercept
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharnmaceuticals, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005133
- Sponsor's protocol ID
- CRFB002AGB16
- Status last verified
- Feb 2017
- First submitted
- 3 Dec 2013
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics
- ClinicalTrials.gov ID
- NCT02005133
- Acronym / sponsor ID
- CRFB002AGB16
- Conditions
- Wet Age-related Macular Degeneration
- Keywords
- Wet age-related macular degeneration
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Dec 2013 (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.
To assess the use of aflibercept over a 2 year period in VEGF inhibitor naive and prior treated wet AMD patients managed in 'real wold' clinic settings.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VEGF inhibitor naïve | – | – |
| VEGF inhibitor prior treated | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects diagnosed with visual impairment due to wet AMD who are undergoing routine assessment in UK opthalmology clinics.
Key inclusion criteria (1 listed)
- Age greater or equal to 50 years Active choroidal neovascularisation secondary to AMD in one or both eyes which in the opinion of the investigator will benefit from treatment with aflibercept Subject willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Patients must not have had any prior use of either bevacizumab or aflibercept
- Other protocol-defined inclusion/exclusion criteria may apply
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
Frequency of aflibercept administration
Time frame: Up to 1 year
To assess the frequency of clinic visits over a 1 year period in VEGF inhibitor naive wet AMD patients managed in 'real world' clinic settings.
4 secondary outcomes
Frequency of clinic visits
Time frame: Up to 1 year
Aflibercept Administration
Time frame: Up to 2 years
Changes in visual acuity from baseline
Time frame: Up to 2 years
Change in central retinal thickness from baseline
Time frame: Up to 2 years
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 28 Feb 2017.
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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.
Novartis Pharnmaceuticals study director
Novartis
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 17 sites in United Kingdom.
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 2 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. 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?
Frequency of aflibercept administration (time frame: Up to 1 year). 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 28 Feb 2017.