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Completed

NCT Number: NCT01249664

VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV)

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.

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Key information

Conditions

Myopia, Pathological Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Myopia Myopia, Degenerative Neovascularization, Pathologic Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Refractive Errors Sensation Disorders Signs and Symptoms Uveal Diseases Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kowloon, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

VEGF Trap-Eye (BAY86-5321)

Biological

1 intravitreal injection of the experimental drug, followed by monthly re-injections if needed

No Drug

Procedure

Sham procedure NOT involving injection of any substance; patient´s eye is anesthetized and a syringe without needle gently pressed on the cornea

Primary outcomes

  1. Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF)

    Time frame: Baseline, Week 24

    Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.

Secondary outcomes

  1. Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach

    Time frame: Baseline, Week 24

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  2. Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases

    Time frame: Baseline, Week 24

    Data as observed at visit, no carrying forward from latest observation if missing data at later time points. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.

  3. Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF

    Time frame: Baseline, Week 24

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  4. Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF

    Time frame: Baseline, Week 24

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  5. Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF

    Time frame: Baseline, Week 48

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  6. Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF

    Time frame: Baseline, Week 48

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  7. Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF

    Time frame: Baseline, Week 48

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  8. Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF

    Time frame: Baseline, Week 24

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  9. Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF

    Time frame: Baseline, Week 24

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  10. Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF

    Time frame: Baseline, Week 24

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  11. Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF

    Time frame: Baseline, Week 48

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  12. Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF

    Time frame: Baseline, Week 48

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  13. Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF

    Time frame: Baseline, Week 48

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

  14. Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF

    Time frame: Baseline, Week 24

    A negative number indicates improvement (reduced thickness).

  15. Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF

    Time frame: Baseline, Week 48

    A negative number indicates improvement (reduced thickness).

  16. Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF

    Time frame: Baseline, Week 24

    CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes

  17. Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF

    Time frame: Baseline, Week 48

    CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes

  18. Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF

    Time frame: Baseline, Week 24

    EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).

  19. Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF

    Time frame: Baseline, Week 24

    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.

  20. Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks

    Time frame: Baseline, Week 24

  21. Mean Change in Area of Leakage From Baseline at Week 24 - LOCF

    Time frame: Baseline, Week 24

    A negative change from baseline indicates improvement, ie, less leakage.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: Myrror

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 30, 2010
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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