check_circleStudy Completed

Myopia, pathological

Bayer Identifier:

15170

ClinicalTrials.gov Identifier:

NCT01249664

EudraCT Number:

Not Available

EU CT Number:

Not Available
VEGF Trap-Eye in choroidal neovascularization secondary to pathologic myopia (mCNV)

Trial purpose

VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to choroidal neovascularization secondary to pathologic myopia. This will be a placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye into the affected eye (and repeated injections if required), and 1 out of 4 patients will receive a sham injection requiring no needle stick, but making the patient unaware of whether or not he received active treatment.
Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham patients may receive active treatment.
Total duration of the study will be 48 weeks.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Able to read (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent form or a family member) and understand the informed consent form and willing to sign the informed consent form
    - Signed informed consent form. In Japan only, the informed consent form for a subject under the age of 20 years will require the co-signature of the subject’s legally authorized representative.
    - Men and women ≥ 18 years of age
    - Myopia of greater than or equal to -6 D OR axial length of greater than or equal to 26.5 mm
    - Active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNV secondary to pathologic myopia as defined by leakage on FA
    - Best-corrected visual acuity of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye at 4 meters
    - Decrease in vision in the study eye is determined by the investigator, using his/her medical judgment, to be primarily the result of the current active mCNV
    - Willing, committed, and able to return for all clinic visits and complete all study-related procedures
  • - Only one functional eye
    - Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
    - Greatest linear dimension (GLD) of the lesion in the study eye is greater than 12 disc areas
    - Recurrent mCNV in the study eye
    - Aphakia in the study eye
    - History or presence of CNV with an origin other than pathologic myopia in the study eye
    - Ocular inflammation or external ocular inflammation in the study eye
    - Concurrent disease in the study eye that would compromise BCVA or require medical or surgical intervention during the study period
    - Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results
    - Significant scarring or atrophy in the fovea that indicates substantial irreversible vision loss in the study eye
    - History of idiopathic or autoimmune-associated uveitis in either eye
    - Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection
    - Vitreomacular traction or traction retinal detachment, epiretinal membrane in either eye
    - Any iris neovascularization and/or vitreous hemorrhage in either eye
    - Uncontrolled glaucoma, or previous filtration surgery in either eye
    - Prior and concomitant treatments
    - In the study eye:
     -- Any prior or concomitant treatment with another investigational agent for mCNV
     -- Any previous panretinal photocoagulation or subfoveal thermal laser therapy
     -- Any prior treatment with photodynamic therapy
     -- Cataract surgery within 3 months prior to Day 1
     -- Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1
     -- Any other intraocular surgery within 3 months prior to Day 1
     -- History of vitreoretinal surgery and/or scleral buckle surgery
    - Any prior treatment with anti-VEGF agents
    - Previous use of intraocular or periocular corticosteroids in either eye within 3 months prior to Day 1
    - Previous assignment to treatment during this study
    - Uncontrolled hypertension
    - History of cerebrovascular disease or myocardial infarction within 6 months prior to Baseline/Day 1
    - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect interpretation of the results of the study, or renders the subject at high risk from treatment complications
    - Women of childbearing potential without contraception, women who intend to breastfeed during the study. All subjects (both men and women) of childbearing potential who are unwilling to use adequate birth control measures during the course of the study.
    - Renal failure requiring dialysis or renal transplant
    - Participation in an investigational study within 30 days prior to Screening/Visit 1 that involved treatment with any drug (excluding vitamins and minerals) or device
    - Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin
    - Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality

Trial summary

Enrollment Goal
122
Trial Dates
December 2010 - August 2013
Phase
Phase 3
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Fukushima Medical University HospitalFukushima, 960-1295, Japan
Completed
Juntendo University Urayasu HospitalUrayasu, 279-0021, Japan
Completed
Tokyo Medical and Dental University HospitalBunkyo-ku, 113-8519, Japan
Completed
Surugadai Nihon University HospitalChiyoda-ku, 101-8309, Japan
Completed
Keio University HospitalShinjuku-ku, 160-8582, Japan
Completed
Nagoya University HospitalNagoya, 466-8560, Japan
Completed
Nagoya City University HospitalNagoya, 467-8602, Japan
Completed
Shiga University of Medical Science HospitalOtsu, 520-2192, Japan
Completed
Kyoto University HospitalKyoto, 606-8507, Japan
Completed
Osaka University HospitalSuita, 565-0871, Japan
Completed
Kyushu University HospitalFukuoka, 812-8582, Japan
Completed
Singapore National Eye CentreSingapore, 168751, Singapore
Completed
Hong Kong Eye HospitalKowloon, Hong Kong
Completed
Seoul St. Mary's HospitalSeoul, 137 701, Korea, Republic Of
Completed
Chang Gung Memorial Hospital at LinkouTaoyuan, 333, Taiwan
Completed
Veterans General HospitalTaipei, 11217, Taiwan
Completed
Matsuyama Red Cross HospitalMatsuyama, 790-8524, Japan
Completed
NTT East Japan Tohoku HospitalSendai, 984-8560, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Osaka City University Medical School HospitalOsaka, 545-8586, Japan

Primary Outcome

  • Mean change in BCVA (best corrected visual acuity)
    date_rangeTime Frame:
    From baseline to week 24
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Proportion of subjects who gain or loose certain amounts of letters
    date_rangeTime Frame:
    Week 24 and Week 48
    enhanced_encryption
    Safety Issue:
    No
  • Changes from baseline in central retinal thickness as assessed by Optical Coherence Tomography (OCT)
    date_rangeTime Frame:
    Week 24 and Week 48
    enhanced_encryption
    Safety Issue:
    No
  • Changes in total Choroidal Neovascularization (CNV) lesion size
    date_rangeTime Frame:
    Week 24 and Week 48
    enhanced_encryption
    Safety Issue:
    No
  • Leakage as found on fundus angiograms
    date_rangeTime Frame:
    Week 24 and Week 48
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase-3, Multi-center, Randomized, Double-masked, Sham-controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Subjects with Choroidal Neovascularization Secondary to Pathologic Myopia
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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