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

NCT ID: NCT01249664

Last Updated: 2014-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-08-31

Brief Summary

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.

Conditions

Myopia, Pathological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

VEGF Trap-Eye (BAY86-5321)

Intervention Type: BIOLOGICAL

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

Arm 2

Group Type: SHAM_COMPARATOR

No Drug

Intervention Type: PROCEDURE

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

Interventions

VEGF Trap-Eye (BAY86-5321)

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

Intervention Type: BIOLOGICAL

No Drug

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Healthcare AG

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Kowloon, , Hong Kong

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Urayasu, Chiba, Japan

Matsuyama, Ehime, Japan

Fukuoka, Fukuoka, Japan

Fukushima, Fukushima, Japan

Kyoto, Kyoto, Japan

Sendai, Miyagi, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Suita, Osaka, Japan

Ōtsu, Shiga, Japan

Bunkyo-ku, Tokyo, Japan

Chiyoda-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Singapore, , Singapore

Seoul, , South Korea

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

Hong Kong; Japan; Singapore; South Korea; Taiwan

Other Identifiers

15170

Identifier Type: -

Identifier Source: org_study_id