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

NCT01249664 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2014-05-05

Study results available
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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

Interventions

BIOLOGICAL

VEGF Trap-Eye (BAY86-5321)

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-02-28
Completion
2013-08-31

Countries

  • Hong Kong
  • Japan
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01249664 on ClinicalTrials.gov