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

NCT01249664 | Completed Phase 3 Results DMC

• 1 other identifier: 15170
• Study Type: interventional
• Target: 122
• Locations: 5 countries
• Sites: 20

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

Keywords

sham-controlled; pathologic myopia; mCNV; choroidal neovascularization; intravitreal injection; vision loss; macular damage

Outcome Measures

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)

  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.

  Baseline, Week 24

Secondary Outcomes (21)

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 48

Study Arms (2)

Arm 1

EXPERIMENTAL

Biological: VEGF Trap-Eye (BAY86-5321)

Arm 2

SHAM COMPARATOR

Procedure: No Drug

Interventions

VEGF Trap-Eye (BAY86-5321) BIOLOGICAL

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

Arm 1

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (20)

Unknown Facility

Kowloon, Hong Kong

Location

Unknown Facility

Nagoya, Aichi-ken, 466-8560, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 467-8602, Japan

Location

Unknown Facility

Urayasu, Chiba, 279-0021, Japan

Location

Unknown Facility

Matsuyama, Ehime, 790-8524, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 812-8582, Japan

Location

Unknown Facility

Fukushima, Fukushima, 960-1295, Japan

Location

Unknown Facility

Kyoto, Kyoto, 606-8507, Japan

Location

Unknown Facility

Sendai, Miyagi, 984-8560, Japan

Location

Unknown Facility

Osaka, Osaka, 545-8586, Japan

Location

Unknown Facility

Osaka, Osaka, 558-8558, Japan

Location

Unknown Facility

Suita, Osaka, 565-0871, Japan

Location

Unknown Facility

Ōtsu, Shiga, 520-2192, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, 101-8309, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Unknown Facility

Singapore, 168751, Singapore

Location

Unknown Facility

Seoul, 137 701, South Korea

Location

Unknown Facility

Taipei, 11217, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Myopia, Degenerative; Choroidal Neovascularization; Vision Disorders

Interventions

aflibercept

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 26, 2010
• First Posted: November 30, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 5, 2014
• Results First Posted: April 1, 2014

Record last verified: 2014-04

Locations

HK (1); JP (15); SG (1); KR (1); TW (2)