VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV) (Myrror)
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Collaborator:
Regeneron Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01249664
First received: November 26, 2010
Last updated: March 19, 2013
Last verified: March 2013
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myopia, Pathological |
Biological: VEGF Trap-Eye (BAY86-5321) Procedure: No Drug |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Mean change in BCVA (best corrected visual acuity) [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects who gain or loose certain amounts of letters [ Time Frame: Week 24 and Week 48 ] [ Designated as safety issue: No ]
- Changes from baseline in central retinal thickness as assessed by Optical Coherence Tomography (OCT) [ Time Frame: Week 24 and Week 48 ] [ Designated as safety issue: No ]
- Changes in total Choroidal Neovascularization (CNV) lesion size [ Time Frame: Week 24 and Week 48 ] [ Designated as safety issue: No ]
- Leakage as found on fundus angiograms [ Time Frame: Week 24 and Week 48 ] [ Designated as safety issue: No ]
| Enrollment: | 122 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Biological: VEGF Trap-Eye (BAY86-5321)
1 intravitreal injection of the experimental drug, followed by monthly re-injections if needed
|
| Sham Comparator: Arm 2 |
Procedure: 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249664
Locations
| Hong Kong | |
| Kowloon, Hong Kong | |
| Japan | |
| Nagoya, Aichi, Japan, 466-8560 | |
| Nagoya, Aichi, Japan, 467-8602 | |
| Urayasu, Chiba, Japan, 279-0021 | |
| Matsuyama, Ehime, Japan, 790-8524 | |
| Sendai, Miyagi, Japan, 984-8560 | |
| Suita, Osaka, Japan, 565-0871 | |
| Otsu, Shiga, Japan, 520-2192 | |
| Bunkyo-ku, Tokyo, Japan, 113-8519 | |
| Chiyoda-ku, Tokyo, Japan, 101-8309 | |
| Shinjuku-ku, Tokyo, Japan, 160-8582 | |
| Fukuoka, Japan, 812-8582 | |
| Fukushima, Japan, 960-1295 | |
| Kyoto, Japan, 606-8507 | |
| Osaka, Japan, 545-8586 | |
| Osaka, Japan, 558-8558 | |
| Korea, Republic of | |
| Seoul, Korea, Republic of, 137 701 | |
| Singapore | |
| Singapore, Singapore, 168751 | |
| Taiwan | |
| Taipei, Taiwan, 11217 | |
| Taoyuan, Taiwan, 333 | |
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01249664 History of Changes |
| Other Study ID Numbers: | 15170 |
| Study First Received: | November 26, 2010 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency Korea: Food and Drug Administration Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) Taiwan: Center for Drug Evaluation Hong Kong: Department of Health |
Keywords provided by Bayer:
|
sham-controlled pathologic myopia mCNV choroidal neovascularization |
intravitreal injection vision loss macular damage |
Additional relevant MeSH terms:
|
Myopia Neovascularization, Pathologic Myopia, Degenerative Choroidal Neovascularization Refractive Errors |
Eye Diseases Metaplasia Pathologic Processes Choroid Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013