Macular DegenerationPhase 4EAGLENCT02689518
EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection
A Phase 4 study testing Intravitreal aflibercept injection in people with Macular Degeneration and Wet Macular Degeneration, run by University of California, San Diego at 1 site in United States.
Trial summary
Clinical and genetic evaluation of individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration (wet AMD) Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Macular Degeneration, Wet 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 12 Nov 2019
- Phase
- Phase 4
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Naïve neovascular wet-AMD (has not received treatment before)
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
- Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either 4.1 require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition, or 4.2 if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 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
Show all 13Show fewer
- 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, ACIOL, or unstable 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)
- Any other condition that the investigator believes would pose a significant hazard to the patient if the investigational therapy were initiated *Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Genetic Assessment of Treatment Response in Patients With Age-related Macular Degeneration Using Intravitreal Aflibercept Injection
Clinical and genetic evaluation of individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration (wet AMD)
Read the detailed description
Clinical and genetic assessment of treatment response in patients with age-related macular degeneration using intravitreal aflibercept injection. This study seeks to determine if different genetic polymorphisms of vascular endothelial growth factor A (VEGF-A) and HtrA serine peptidase 1(HTRA1) and other genes correlate to the response to intravitreal aflibercept injection therapy.
- Conditions
- Macular Degeneration, Wet Macular Degeneration
- Being tested
- Intravitreal aflibercept injection
- Keywords
- AMD, Wet AMD, Macular degeneration, Wet macular degeneration, Neovascularization, Retina, Retinal degeneration
- Medical subject headings
- Macular Degeneration, Wet Macular Degeneration, Neovascularization, Pathologic, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal aflibercept injectionDrug
Also called Eylea
Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - On-Label | Other | On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months Receives: Drug: Intravitreal aflibercept injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic Response
The primary endpoint in the study is the correlation of CFH, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies and VEGA expression in lymphoblastoid cell lines with response to intravitreal aflibercept injection treatment, based on anatomic outcomes:
Early response (at Month 3) - o On optical coherence tomography(SD-OCT)
- Reduction in central retinal thickness by ≥ 50%, OR
- Central retinal thickness <300 um, OR
- Absence of retinal fluid
Later response (at Month 12) -
- On SD-OCT
- Reduction in central retinal thickness by ≥ 50%, OR
- Central retinal thickness < 300 um, OR
- Absence of retinal fluid
Poor response, defined as no reduction of fluid or central retinal thickness at Month 12.
Measured: 12 Months
Secondary outcomes (1)
Visual/Treatment Response
The secondary endpoints are a correlation of CFH, VEGF, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies:
With visual outcomes -
- Early response, defined as a gain ≥ 0 letters at Month 3
- Later response, defined as a gain ≥ 0 letters at Month 12
- Poor response, defined as loss of visual acuity (gain <0 letters) at Month 12
With change in characteristics on fluorescein angiography and fundus photography (lesion size, lesion type, etc)
With number of injections through Month 12
- Mean number of intravitreal aflibercept injections required through Month 12 will be calculated for the group overall, and separately by response group (early, later, and no response to treatment).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startApr 2014
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Michael Goldbaum, MD, University of California, San Diego
- Investigators
- Michael Goldbaum, M.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689518
- Sponsor's protocol ID
- EAGLE
- Acronym
- EAGLE
- Status last verified
- Mar 2021
- First submitted
- 21 Apr 2014
- Last updated
- 25 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Genetic Assessment of Treatment Response in Patients With Age-related Macular Degeneration Using Intravitreal Aflibercept Injection
- ClinicalTrials.gov ID
- NCT02689518
- Acronym / sponsor ID
- EAGLE / EAGLE
- Conditions
- Macular Degeneration, Wet Macular Degeneration
- Keywords
- AMD, Wet AMD, Macular degeneration, Wet macular degeneration, Neovascularization, Retina, Retinal degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Apr 2014 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Posted 25 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical and genetic evaluation of individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration (wet AMD)
Detailed description
Clinical and genetic assessment of treatment response in patients with age-related macular degeneration using intravitreal aflibercept injection. This study seeks to determine if different genetic polymorphisms of vascular endothelial growth factor A (VEGF-A) and HtrA serine peptidase 1(HTRA1) and other genes correlate to the response to intravitreal aflibercept injection therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment - On-Label | Other | Drug: Intravitreal aflibercept injectionOn-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years
- Naïve neovascular wet-AMD (has not received treatment before)
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key exclusion criteria (13 listed)
- Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
- Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either 4.1 require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition, or 4.2 if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the study period
- Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either 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 injectionAlso: EyleaIntravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months. | Drug | Treatment - On-Label |
Primary outcome
Anatomic Response
Time frame: 12 Months
The primary endpoint in the study is the correlation of CFH, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies and VEGA expression in lymphoblastoid cell lines with response to intravitreal aflibercept injection treatment, based on anatomic outcomes: Early response (at Month 3) - o On optical coherence tomography(SD-OCT) * Reduction in central retinal thickness by ≥ 50%, OR * Central retinal thickness <300 um, OR * Absence of retinal fluid Later response (at Month 12) - o On SD-OCT * Reduction in central retinal thickness by ≥ 50%, OR * Central retinal thickness < 300 um, OR * Absence of retinal fluid Poor response, defined as no reduction of fluid or central retinal thickness at Month 12.
1 secondary outcome
Visual/Treatment Response
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- 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.
Michael Goldbaum, M.D. principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravitreal aflibercept injection in people with Macular Degeneration and Wet Macular Degeneration, run by University of California, San Diego 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 4 inclusion and 13 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 25 Mar 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2021). 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?
Anatomic Response (time frame: 12 Months). 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 25 Mar 2021.