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

Bayer

Status and phase

Completed

Phase 3

Conditions

Myopia, Pathological

Treatments

Biological: VEGF Trap-Eye (BAY86-5321)

Procedure: No Drug

Study type

Interventional

Funder types

Industry

Identifiers

NCT01249664

15170

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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