check_circleStudy Completed

Myopia, pathological

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

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
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    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
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    Safety Issue:
    No
  • Changes in total Choroidal Neovascularization (CNV) lesion size
    date_rangeTime Frame:
    Week 24 and Week 48
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    Safety Issue:
    No
  • Leakage as found on fundus angiograms
    date_rangeTime Frame:
    Week 24 and Week 48
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    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