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EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection (EAGLE)

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ClinicalTrials.gov Identifier: NCT02689518
Recruitment Status : Unknown
Verified February 2016 by Kang Zhang, MD, PhD, University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Kang Zhang, MD, PhD, University of California, San Diego

Brief Summary:
Clinical and genetic evaluation of individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration (wet AMD)

Condition or disease Intervention/treatment Phase
Macular Degeneration Wet Macular Degeneration Drug: Intravitreal aflibercept injection Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Genetic Assessment of Treatment Response in Patients With Age-related Macular Degeneration Using Intravitreal Aflibercept Injection
Study Start Date : April 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Treatment - On-Label
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
Drug: Intravitreal aflibercept injection
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.
Other Name: Eylea




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Visual/treatment response [ Time Frame: 12 Months ]

    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

    o 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).



Other Outcome Measures:
  1. Safety - Incidence and severity of ocular and non-ocular adverse events [ Time Frame: 12 Months ]
    Incidence and severity of ocular and non-ocular adverse events using Aflibercept intravitreal injections will also be evaluated.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 50 years
  2. Naïve neovascular wet-AMD (has not received treatment before)
  3. Willing and able to comply with clinic visits and study-related procedures
  4. Provide signed informed consent

Exclusion Criteria:

  1. Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD
  2. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
  3. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
  4. 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
  5. Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
  6. Current vitreous hemorrhage in the study eye
  7. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  8. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  9. Aphakia, ACIOL, or unstable PCIOL
  10. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
  11. Pregnant or breast-feeding women
  12. 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)
  13. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689518


Contacts
Contact: Cindy Wen, B.S. (858)246-0814 cwen@ucsd.edu

Locations
United States, California
Shiley Eye Center Recruiting
La Jolla, California, United States, 92126
Contact: Cindy Wen, B.S.    858-246-0814    cwen@ucsd.edu   
Principal Investigator: Kang Zhang, M.D., Ph.D.         
Sponsors and Collaborators
University of California, San Diego
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Kang Zhang, M.D., Ph.D. UCSD

Responsible Party: Kang Zhang, MD, PhD, Professor of Ophthalmology and Human Genetics, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02689518     History of Changes
Other Study ID Numbers: EAGLE
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Keywords provided by Kang Zhang, MD, PhD, University of California, San Diego:
AMD
Wet AMD
Macular degeneration
Wet macular degeneration
Neovascularization
Retina
Retinal degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases