Age-Related Macular DegenerationATLASNCT01773954
Repeated Eye Injections of Aflibercept for Treatment of Wet Age Related Macular Degeneration
A study testing Intravitreal Aflibercept Injection in people with Age-Related Macular Degeneration and Macular Degeneration, run by MidAtlantic Retina at 3 sites in United States.
Trial summary
To evaluate the visual outcome and number of injections required during an optical coherence tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular age-related macular degeneration (NVAMD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Macular Degeneration
- What is being tested?
- Intravitreal Aflibercept Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 55 years with treatment naïve, active subfoveal NVAMD demonstrating macular fluid on optical coherence tomography (OCT) and leakage on fluorescein angiography (FA).
- Only one eye for each patient demonstrating a pre-treatment acuity of 20/25 - 20/320 is eligible
- Patients cannot have concurrent progressive retinal disease in the study eye.
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Prior treatment for NVAMD in the study eye,
- Prior experimental treatment of NVAMD in either eye
- Prior treatment with systemic anti-VEGF (vascular endothelial growth factor) agents
- Prior treatment with verteporfin, plaque brachytherapy, or external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- History of vitreo surgical intervention in the study eye. Cataract surgery is permitted.
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- Concurrent eye disease in the study eye that could compromise visual acuity (e.g. diabetic retinopathy, advanced glaucoma)
- Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either
- require medical or surgical intervention during the 52 weeks study period to prevent or treat visual loss that might result from that condition, or
- allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 52 weeks study period
- Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
- Current vitreous hemorrhage in the study eye
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Aphakia, Anterior Chamber Intraocular Lens (ACIOL), or unstable Posterior Chamber Intraocular Lens (PCIOL).
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
- Pregnant or breast-feeding women
- Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mid Atlantic Retina- Cherry Hill
Cherry Hill, New Jersey, 08002
Mid Atlantic Retina- Huntingdon Valley
Huntingdon Valley, Pennsylvania, 19006
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Optical Coherence Tomography Guided Treat and Extend Therapy for Neovascular Age Related Macular Degeneration Using Aflibercept (the ATLAS Study)
To evaluate the visual outcome and number of injections required during an optical coherence tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular age-related macular degeneration (NVAMD).
Read the detailed description
The purpose of this study is to see how using "treat and extend," a method of determining how often a patient with NVAMD should visit the retina clinic and receive treatments, affects vision in patients with this condition after treatment. The treatment the investigators are using in this study is an eye injection of a drug called aflibercept (also called EYLEA). Eylea is FDA (Food and Drug Administration) approved for treatment of wet age related macular degeneration.
The investigators hope that "treat and extend" strikes the right balance between making sure patients get all of the treatments needed, but not giving patients too many treatments (so that the side effects of treatments are minimized and so that patients don't have to make more visits than they need to maintain maximum visual gain). The experimental part of this study is determining this "right balance" of eye injections.
- Being tested
- Intravitreal Aflibercept Injection
- Keywords
- amd, age related macular degeneration, macular degeneration, neovascular
- Medical subject headings
- Macular Degeneration, Glycogen Storage Disease Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept InjectionDrug
Increased or decreased time between visits
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Aflibercept Injection More | Experimental | Patient receives treatment at baseline and week 4 visit. The first time extension criteria are met the follow-up interval will be increased by 4 weeks. Each time the extension criteria is met the interval will be extended by 2 weeks to a maximum of 16 weeks. If a patient is being followed at an 8 week interval but fails to meet extension criteria at a particular visit, treatment will be administered as usual and the follow up interval will be reduced to 4 weeks. If patient is being followed at 10-16 week interval but fails to meet extension criteria at a particular visit, treatment will be administered but the follow-up interval will be reduced by 2 week increments. Receives: Drug: Intravitreal Aflibercept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-Related 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MidAtlantic Retina
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, MidAtlantic Retina, Wills Eye
- Investigators
- Carl Regillo, MD, Principal investigator, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773954
- Sponsor's protocol ID
- ATLAS
- Other IDs
- 20122054
- Acronym
- ATLAS
- Status last verified
- Apr 2018
- First submitted
- 17 Jan 2013
- Last updated
- 2 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Guided Treat and Extend Therapy for Neovascular Age Related Macular Degeneration Using Aflibercept (the ATLAS Study)
- ClinicalTrials.gov ID
- NCT01773954
- Acronym / sponsor ID
- ATLAS / ATLAS
- Keywords
- amd, age related macular degeneration, macular degeneration, neovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MidAtlantic RetinaUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Feb 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 2 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the visual outcome and number of injections required during an optical coherence tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular age-related macular degeneration (NVAMD).
Detailed description
The purpose of this study is to see how using "treat and extend," a method of determining how often a patient with NVAMD should visit the retina clinic and receive treatments, affects vision in patients with this condition after treatment. The treatment the investigators are using in this study is an eye injection of a drug called aflibercept (also called EYLEA). Eylea is FDA (Food and Drug Administration) approved for treatment of wet age related macular degeneration.
The investigators hope that "treat and extend" strikes the right balance between making sure patients get all of the treatments needed, but not giving patients too many treatments (so that the side effects of treatments are minimized and so that patients don't have to make more visits than they need to maintain maximum visual gain). The experimental part of this study is determining this "right balance" of eye injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Aflibercept Injection More | Experimental | Drug: Intravitreal Aflibercept InjectionPatient receives treatment at baseline and week 4 visit. The first time extension criteria are met the follow-up interval will be increased by 4 weeks. Each time the extension criteria is met the interval will be extended by 2 weeks to a maximum of 16 weeks. If a patient is being followed at an 8 week interval but fails to meet extension criteria at a particular visit, treatment will be administered as usual and the follow up interval will be reduced to 4 weeks. If patient is being followed at 10-16 week interval but fails to meet extension criteria at a particular visit, treatment will be administered but the follow-up interval will be reduced by 2 week increments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 55 years with treatment naïve, active subfoveal NVAMD demonstrating macular fluid on optical coherence tomography (OCT) and leakage on fluorescein angiography (FA).
- Only one eye for each patient demonstrating a pre-treatment acuity of 20/25 - 20/320 is eligible
- Patients cannot have concurrent progressive retinal disease in the study eye.
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key exclusion criteria (18 listed)
- Prior treatment for NVAMD in the study eye,
- Prior experimental treatment of NVAMD in either eye
- Prior treatment with systemic anti-VEGF (vascular endothelial growth factor) agents
- Prior treatment with verteporfin, plaque brachytherapy, or external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
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 |
|---|---|---|
| Intravitreal Aflibercept InjectionIncreased or decreased time between visits | Drug | Intravitreal Aflibercept Injection More |
Primary outcome
Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score
Time frame: Baseline to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carl Regillo, MD principal investigator
Wills Eye Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal Aflibercept Injection in people with Age-Related Macular Degeneration and Macular Degeneration, run by MidAtlantic Retina at 3 sites 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 5 inclusion and 18 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 2 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score (time frame: Baseline to Week 52). 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 2 May 2018.